AzTrials
AzTrials

StrokePhase 3NAVIGATE ESUSNCT02313909

Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Acetylsalicylic acid (Aspirin, BAY1019036) in people with Stroke, run by Bayer at 454 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Stroke
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Acetylsalicylic acid (Aspirin, BAY1019036)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,213 participants
Where
454 sitesin 31 countries
Study dates
23 Dec 2014to 15 Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recent ESUS (between 7 days and 6 months), defined as:
  • Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
  • Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and
  • No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
  • No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
  • No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)

Who cannot join

  • Severely disabling stroke (modified Rankin score ≥4)
  • Indication for chronic anticoagulation or antiplatelet therapy
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

Trial locations and contacts

454 sites in 31 countries.

454 sites in 31 countries

Japan44 sites

  • Study site

    Asahikawa, Hokkaido, 070-8530

  • Study site

    Bunkyo-ku, Tokyo, 113-8603

  • Study site

    Fukuoka, 810-0001

  • Study site

    Fukuoka, 810-8563

  • Study site

    Fukuoka, 811-0213

  • Study site

    Fukuyama, Hiroshima, 720-0825

  • Study site

    Hachiōji, Tokyo, 192-0032

  • Study site

    Hakodate, Hokkaido, 041-0802

  • Study site

    Hidaka, Saitama, 350-1298

  • Study site

    Hiroshima, 730-8518

  • Study site

    Isehara, Kanagawa, 259-1193

  • Study site

    Kakogawa, 675-0122

  • Study site

    Kawasaki, Kanagawa, 216-8511

  • Study site

    Kitakyushu, Fukuoka, 802-8555

  • Study site

    Kitakyushu, Fukuoka, 805-0050

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kobe, Hyōgo, 652-0803

  • Study site

    Kobe, Hyōgo, 654-0048

  • Study site

    Kochi, 780-8522

  • Study site

    Kodaira, Tokyo, 187-8510

  • Study site

    Kōriyama, Fukushima, 963-8052

  • Study site

    Kurashiki, Okayama-ken, 710-8602

  • Study site

    Kushiro, Hokkaido, 085-0061

  • Study site

    Kyoto, 600-8558

  • Study site

    Kyoto, 601-1495

  • Study site

    Kyoto, 602-8026

  • Study site

    Matsubara, Osaka, 580-0032

  • Study site

    Musashino, Tokyo, 180-8610

  • Study site

    Nagoya, Aichi-ken, 454-8502

  • Study site

    Nagoya, Aichi-ken, 457-8511

  • Study site

    Nagoya, Aichi-ken, 460-0001

  • Study site

    Niigata, 950-1197

  • Study site

    Nishinomiya, Hyōgo, 663-8211

  • Study site

    Okayama, 700-8557

  • Study site

    Okazaki, Aichi-ken, 444-8553

  • Study site

    Sakai, Osaka, 590-0064

  • Study site

    Sasebo, Nagasaki, 857-0134

  • Study site

    Sendai, Miyagi, 982-8523

  • Study site

    Seto, Aichi-ken, 489-8642

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Suita, Osaka, 565-8565

  • Study site

    Sumida-ku, Tokyo, 130-8575

  • Study site

    Tenri, Nara, 632-8552

  • Study site

    Toyota, Aichi-ken, 471-8513

Other trials in Japan

United States38 sites

  • Study site

    Ann Arbor, Michigan, 48109-0330

  • Study site

    Austin, Texas, 78701

  • Study site

    Baltimore, Maryland, 21210

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Buffalo, New York, 14203

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44106-2602

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbia, South Carolina, 29203-8004

  • Study site

    Dallas, Texas, 75390

  • Study site

    El Paso, Texas, 79905-2709

  • Study site

    Erie, Pennsylvania, 16550

  • Study site

    Gainesville, Florida, 32611

  • Study site

    Houston, Texas, 77030

  • Study site

    Iowa City, Iowa, 52242-1089

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Long Beach, California, 90806

  • Study site

    Mount Clemens, Michigan, 48043

  • Study site

    Nashville, Tennessee, 37232-5400

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New Haven, Connecticut, 06520-8064

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10016-4576

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Portland, Oregon, 97225

  • Study site

    Portland, Oregon, 97239-3011

  • Study site

    Salt Lake City, Utah, 84312

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Seattle, Washington, 98102

  • Study site

    Stanford, California, 94305-5119

  • Study site

    Temple, Texas, 76504

  • Study site

    Torrance, California, 90502

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Worcester, Massachusetts, 01655

Other trials in United States

China33 sites

  • Study site

    Baoji, Shanxi, 721008

  • Study site

    Baotou, Inner Mongolia, 014010

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100730

  • Study site

    Changchun, Jilin, 130021

  • Study site

    Changsha, Hunan, 410008

  • Study site

    Chongqing

  • Study site

    Foshan, Guangdong, 528000

  • Study site

    Fuzhou, Fujian, 350001

  • Study site

    Fuzhou, Fujian, 350005

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou

  • Study site

    Haikou, Hainan, 570311

  • Study site

    Hangzhou, Zhejiang, 310009

  • Study site

    Harbin, Heilongjiang

  • Study site

    Kunming, Yunnan, 650032

  • Study site

    Lanzhou, Gansu, 730000

  • Study site

    Nanchang, Jiangxi, 330006

  • Study site

    Nantong, Jiangsu, 226001

  • Study site

    Qingdao, Shandong, 266003

  • Study site

    Shanghai, 200032

  • Study site

    Shenyang, Liaoning, 110016

  • Study site

    Shijiazhuang, Hebei, 050000

  • Study site

    Taizhou, Zhejiang, 317000

  • Study site

    Tianjin, 300000

  • Study site

    Tianjin, 300052

  • Study site

    Wenzhou, Zhejiang, 325000

  • Study site

    Wuhan, Hubei, 430014

  • Study site

    Wuhan, Hubei, 430034

  • Study site

    Wuhan, Hubei, 430060

  • Study site

    Xi’an, Shanxi, 710038

  • Study site

    Yantai, Shandong, 264000

  • Study site

    Zhengzhou, Henan, 450052

Other trials in China

United Kingdom33 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Ashford, Kent, TN24 0LZ

  • Study site

    Boston, Lincolnshire, PE21 9QS

  • Study site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Study site

    Colchester, Essex, CO4 5JR

  • Study site

    Durham, DH1 5TW

  • Study site

    Edinburgh, EH16 4SA

  • Study site

    Exeter, Devon, EX2 5DW

  • Study site

    Gateshead, Tyne and Wear, NE9 6SX

  • Study site

    Glasgow, Stratchclyde, G51 4TF

  • Study site

    Gloucester, Gloucestershire, GL1 3NN

  • Study site

    Great Yarmouth, Norfolk, NR31 6LA

  • Study site

    Harrow, London, HA1 3UJ

  • Study site

    High Wycombe, Buckinghamshire, HP11 2TT

  • Study site

    Leeds, West Yorkshire, LS1 3EX

  • Study site

    Leicester, Leicestershire, LE2 7LX

  • Study site

    London, N18 1QX

  • Study site

    London, SE5 8AF

  • Study site

    London, W6 8RP

  • Study site

    London, WC1N 3BG

  • Study site

    Luton, LU4 0DZ

  • Study site

    Margate, Kent, CT9 4AN

  • Study site

    Milton Keynes, Buckinghamshire, MK6 5LD

  • Study site

    Norwich, NR4 7UY

  • Study site

    Salisbury, Wiltshire, SP2 8BJ

  • Study site

    Sheffield, South Yorkshire, S10 2JF

  • Study site

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Study site

    Sunderland, Tyne and Wear, SR4 7TP

  • Study site

    Taunton, Somerset, TA1 5DA

  • Study site

    Watford, Hertfordshire, WD1 8HB

  • Study site

    Westcliff-on-Sea, Essex, SS0 0RY

  • Study site

    Wolverhampton, West Midlands, WV10 0QP

  • Study site

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Spain26 sites

  • Study site

    A Coruña, 15006

  • Study site

    Badajoz, 06080

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

  • Study site

    Bilbao, 48013

  • Study site

    Cáceres, 10003

  • Study site

    Castellon, Castellón, 12004

  • Study site

    El Palmar (Murcia), Murcia, 30120

  • Study site

    Girona, 17007

  • Study site

    Granada, 18014

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    León, 24008

  • Study site

    Lleida, 25198

  • Study site

    Madrid, 28006

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28046

  • Study site

    Sant Joan Despí, Barcelona, 08970

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Seville, 41009

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46026

  • Study site

    Valladolid, 47011

  • Study site

    Zaragoza, 50009

Other trials in Spain

Canada23 sites

  • Study site

    Brandon, Manitoba, R7A 2B3

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Chicoutimi, Quebec, G7H 5H6

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Edmonton, Alberta, T6L 5X8

  • Study site

    Halifax, Nova Scotia, B3H 2Y5

  • Study site

    Hamilton, Ontario, L8L 2X2

  • Study site

    Kingston, Ontario, K7L 2V7

  • Study site

    Lethbridge, Alberta, T1K 0C9

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    London, Ontario, N6G 2V4

  • Study site

    Mississauga, Ontario, L5B 2V2

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Québec, G1J 1Z4

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Study site

    Thunder Bay, Ontario, P7K 0A4

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Italy20 sites

  • Study site

    Ancona, The Marches, 60126

  • Study site

    Cagliari, Sardinia, 09134

  • Study site

    Isernia, Molise, 86077

  • Study site

    L’Aquila, Abruzzo, 67100

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Perugia, Umbria, 06012

  • Study site

    Perugia, Umbria, 06024

  • Study site

    Perugia, Umbria, 06156

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00161

  • Study site

    Rome, Lazio, 00168

  • Study site

    Trieste, Friuli Venezia Giulia, 34100

  • Study site

    Verona, Veneto, 37024

  • Study site

    Verona, Veneto, 37126

  • Study site

    Vibo Valentia, Calabria, 89900

Other trials in Italy

Germany17 sites

  • Study site

    Altenburg, Thuringia, 04600

  • Study site

    Berlin, 12200

  • Study site

    Dresden, Saxony, 01129

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Hamburg, 22417

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    Markkleeberg, Saxony, 04416

  • Study site

    Meerbusch, North Rhine-Westphalia, 40670

  • Study site

    München, Bavaria, 81675

  • Study site

    Regensburg, Bavaria, 93053

  • Study site

    Wermsdorf, Saxony, 04779

  • Study site

    Wuppertal, North Rhine-Westphalia, 42283

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

Russia17 sites

  • Study site

    Chelyabinsk, 454021

  • Study site

    Kaluga, 248010

  • Study site

    Kazan', 420012

  • Study site

    Krasnoyarsk, 660022

  • Study site

    Moscow, 117997

  • Study site

    Moscow, 119049

  • Study site

    Nizhny Novgorod, 603005

  • Study site

    Saint Petersburg, 190068

  • Study site

    Saint Petersburg, 191186

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 196247

  • Study site

    Tomsk, 634063

  • Study site

    Ulyanovsk, 432063

  • Study site

    Volgograd, 400131

  • Study site

    Yaroslavl, 150000

  • Study site

    Yekaterinburg, 620017

  • Study site

    Yekaterinburg, 620102

Other trials in Russia

France16 sites

  • Study site

    Antony, 92166

  • Study site

    Bordeaux, 33000

  • Study site

    Brest, 29609

  • Study site

    Caen, 14033

  • Study site

    Dijon, 21033

  • Study site

    Le Chesnay, 78150

  • Study site

    Limoges, 87042

  • Study site

    Nantes, 44035

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75012

  • Study site

    Paris, 75018

  • Study site

    Paris, 75475

  • Study site

    Paris, 75634

  • Study site

    Paris, 75674

  • Study site

    Saint-Priest-en-Jarez, 42270

  • Study site

    Strasbourg, 67091

Other trials in France

Argentina15 sites

  • Study site

    Banfield, Buenos Aires, 1828

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1078

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1428

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1039AAO

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1221 ADC

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1431FWO

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1437JCP

  • Study site

    Ciudad Auton. de Buenos Aires, Buenos Aires, C1405CNF

  • Study site

    Ciudad Auton. de Buenos Aires, C1425DND

  • Study site

    Córdoba, X5000JHQ

  • Study site

    Mar del Plata, Buenos Aires, B7602CBM

  • Study site

    Rosario, Santa Fe Province, S2000DSV

  • Study site

    Rosario, Santa Fe Province

  • Study site

    San Martín, Buenos Aires, 1650

  • Study site

    Santa Fe, 3000

Other trials in Argentina

Brazil15 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30130-100

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Botucatu, São Paulo, 18618 970

  • Study site

    Campinas, São Paulo, 13081-000

  • Study site

    Joinville, Santa Catarina, 89202-165

  • Study site

    Matão, São Paulo, 15990-060

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Study site

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Ribeirão Preto, São Paulo, 14015-130

  • Study site

    Ribeirão Preto, São Paulo, 14048-900

  • Study site

    Rio de Janeiro, 22281-100

  • Study site

    Salvador, Estado de Bahia, 41253-190

  • Study site

    São Paulo, São Paulo, 01228-000

  • Study site

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

Poland15 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Chełm, 22-100

  • Study site

    Gdansk, 80-803

  • Study site

    Gdansk, 80-952

  • Study site

    Gmina Końskie, 26-200

  • Study site

    Katowice, 40-635

  • Study site

    Lodz, 90-153

  • Study site

    Lodz, 90-549

  • Study site

    Olsztyn, 10-561

  • Study site

    Sandomierz

  • Study site

    Siedlce, 08-110

  • Study site

    Skarżysko-Kamienna, 26-110

  • Study site

    Warsaw, 00-146

  • Study site

    Warsaw, 02957

  • Study site

    Warsaw, 03-242

Other trials in Poland

South Korea15 sites

  • Study site

    Anyang-si, Gyeonggido, 431-070

  • Study site

    Busan, 49201

  • Study site

    Daegu, 41931

  • Study site

    Daegu, 42415

  • Study site

    Donggu, Gwangju Gwang''yeogsi, 61469

  • Study site

    Goyang, Gyeonggido, 411-706

  • Study site

    Incheon

  • Study site

    Seongnam-si, Gyeonggido, 463-707

  • Study site

    Seoul, Seoul Teugbyeolsi, 152-703

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 130-872

  • Study site

    Seoul, 139-872

Other trials in South Korea

Hungary13 sites

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1134

  • Study site

    Budapest, 1204

  • Study site

    Debrecen, 4012

  • Study site

    Eger, 3300

  • Study site

    Győr, 9002

  • Study site

    Kistarcsa, 2143

  • Study site

    Miskolc, 35-26

  • Study site

    Nagykanizsa, 8800

  • Study site

    Nyíregyháza, H-4400

  • Study site

    Sopron, 9400

  • Study site

    Szeged, 6720

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia11 sites

  • Study site

    Blansko, 67801

  • Study site

    Brno, 625 00

  • Study site

    Brno, 656 91

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 58633

  • Study site

    Olomouc, 775 20

  • Study site

    Ostrava Vitkovice

  • Study site

    Ostrava-Poruba, 708 52

  • Study site

    Prague, 10034

  • Study site

    Prague, 128 21

  • Study site

    Vyškov, 682 01

Other trials in Czechia

Australia10 sites

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Elizabeth Vale, 5112

  • Study site

    Footscray, Victoria, 3011

  • Study site

    Launceston, Tasmania, 7250

  • Study site

    Murdoch, Western Australia, 6150

  • Study site

    Nedlands, 6009

  • Study site

    Southport, Queensland, 4215

  • Study site

    Waratah, New South Wales, 2298

Other trials in Australia

Austria10 sites

  • Study site

    Bad Pirawarth, Lower Austria, 2222

  • Study site

    Feldbach, Styria, 8330

  • Study site

    Feldkirch, Vorarlberg, 6807

  • Study site

    Klagenfurt, Carinthia, 9020

  • Study site

    Salzburg, 5020

  • Study site

    Sankt Pölten, Lower Austria, 3100

  • Study site

    Vienna, 1020

  • Study site

    Vienna, 1090

  • Study site

    Villach, Carinthia, 9500

  • Study site

    Vöcklabruck, Upper Austria, 4840

Other trials in Austria

Chile8 sites

  • Study site

    Los Ángeles, Bío-Bío

  • Study site

    Osorno, Los Lagos Region

  • Study site

    Port Montt, Los Lagos Region, 5506667

  • Study site

    Santiago, 7650567

  • Study site

    Santiago, 8420524

  • Study site

    Valdivia, Los Lagos Region

  • Study site

    Viña del Mar, Valparaiso

  • Study site

    Viña del Mar

Other trials in Chile

Israel8 sites

  • Study site

    Ashkelon, 7827804

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3339419

  • Study site

    Haifa, 3436212

  • Study site

    Jerusalem

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 5262000

  • Study site

    Tel Aviv, 6423906

Other trials in Israel

Mexico8 sites

  • Study site

    Aguascalientes, 20127

  • Study site

    Gustavo Adolfo Madero, Mexico City, 07760

  • Study site

    Mérida, Yucatán, 97070

  • Study site

    México D.F., México, 06720

  • Study site

    México D.F.

  • Study site

    México, D.F., Mexico City, 14080

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Morelia, Michoacán, 58000

Other trials in Mexico

Portugal8 sites

  • Study site

    Almada, 2801-951

  • Study site

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About this study

Official title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Conditions
Stroke
Being tested
Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic acid (Aspirin, BAY1019036), Rivaroxaban-Placebo, Aspirin-Placebo
Keywords
Rivaroxaban, Xarelto, Aspirin, Acetylsalicylic acid (ASA), Oral Anticoagulant, Blood Thinner, Stroke, Ischemic Stroke, Cryptogenic Stroke, Embolic stroke of undetermined source, ESUS, Transient Ischemic Attack, Thromboembolism, Cerebrovascular Disease
Medical subject headings
Stroke, Ischemic Stroke, Ischemic Attack, Transient, Thromboembolism, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    15 mg, once daily, orally, tablet

  • Acetylsalicylic acid (Aspirin, BAY1019036)Drug

    100 mg, once daily, orally, tablet

  • Rivaroxaban-PlaceboOther

    Matching placebo, once daily, orally, tablet

  • Aspirin-PlaceboOther

    Matching placebo, once daily, orally, tablet

Study groups in NCT02313909
Study groupRoleWhat they receive
RivaroxabanExperimentalRivaroxaban 15 mg orally once daily
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Other: Rivaroxaban-Placebo
AspirinActive comparatorAspirin 100 mg orally once daily
Receives: Drug: Acetylsalicylic acid (Aspirin, BAY1019036); Other: Aspirin-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

    Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  2. Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

    Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

Secondary outcomes (6)

  1. Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction

    Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  2. Incidence Rate of All-Cause Mortality

    All-cause mortality includes all deaths of participants due to any cause.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  3. Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction

    Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  4. Incidence Rate of Life-Threatening Bleeding Events

    Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  5. Incidence Rate of Clinically Relevant Non-Major Bleeding Events

    Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

  6. Incidence Rate of Intracranial Hemorrhage

    Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.

    Measured: From randomization until the efficacy cut-off date (median 326 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2014 (estimated)
  2. Study start23 Dec 2014
  3. Primary completion15 Feb 2018
  4. Study completion15 Feb 2018

Why it stopped: Study halted early due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study were completed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313909
Sponsor's protocol ID
16573
Other IDs
2013-000768-27
Acronym
NAVIGATE ESUS
Status last verified
Dec 2018
First submitted
8 Dec 2014
Last updated
9 Jan 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hart RG, Sharma M, Mundl H, Kasner SE, Bangdiwala SI, Berkowitz SD, Swaminathan B, Lavados P, Wang Y, Wang Y, Davalos A, Shamalov N, Mikulik R, Cunha L, Lindgren A, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi RJ, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni D, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, Endres M, Muir KW, Bornstein N, Ozturk S, O'Donnell MJ, De Vries Basson MM, Pare G, Pater C, Kirsch B, Sheridan P, Peters G, Weitz JI, Peacock WF, Shoamanesh A, Benavente OR, Joyner C, Themeles E, Connolly SJ; NAVIGATE ESUS Investigators. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.

    PubMed 29766772

  • Kasner SE, Lavados P, Sharma M, Wang Y, Wang Y, Davalos A, Shamalov N, Cunha L, Lindgren A, Mikulik R, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi R, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni DS, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, DeVries Basson MM, Endres M, Muir K, Bornstein N, Ozturk S, O'Donnell M, Mundl H, Pater C, Weitz J, Peacock WF, Swaminathan B, Kirsch B, Berkowitz SD, Peters G, Pare G, Themeles E, Shoamanesh A, Connolly SJ, Hart RG; NAVIGATE ESUS Steering Committee and Investigators. Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.

    PubMed 29525076

  • Hart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154. doi: 10.1177/2396987316663049. Epub 2016 Aug 3.

    PubMed 31008276

  • Lee SF, Whiteley W, Bosch J, Sherlock L, Cukierman-Yaffe T, O'Donnell M, Eikelboom JW, Gerstein HC, Bangdiwala SI, Muniz-Terrera G. Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches. Trials. 2024 Oct 2;25(1):644. doi: 10.1186/s13063-024-08482-2.

    PubMed 39358761

  • Sharma M, Smith EE, Pearce LA, Perera KS, Kasner SE, Yoon BW, Ameriso SF, Puig J, Damgaard D, Fiebach JB, Muir KW, Veltkamp RC, Toni DS, Shamalov N, Gagliardi RJ, Mikulik R, Engelter ST, Bereczki D, O'Donnell MJ, Saad F, Shoamanesh A, Berkowitz SD, Mundl H, Hart RG; NAVIGATE ESUS MRI Substudy Investigators. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. Int J Stroke. 2022 Aug;17(7):799-805. doi: 10.1177/17474930211058012. Epub 2021 Nov 18.

    PubMed 34791941

  • Merkler AE, Pearce LA, Kasner SE, Shoamanesh A, Birnbaum LA, Kamel H, Sheth KN, Sharma R. Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Dec 1;78(12):1454-1460. doi: 10.1001/jamaneurol.2021.3828.

    PubMed 34694346

  • Sharma M, Smith EE, Pearce LA, Shoamanesh A, Perera KS, Coutts SB, Damgaard D, Ameriso SF, Rha JH, Modrau B, Yoon BW, Romano M, Messe SR, Barlinn J, Lambeck J, Saad F, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS MIND MRI Substudy Investigators. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial. Stroke. 2022 Jan;53(1):45-52. doi: 10.1161/STROKEAHA.120.032976. Epub 2021 Sep 20.

    PubMed 34538089

  • Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Marti-Fabregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836.

    PubMed 33074284

  • Scheitz JF, Pare G, Pearce LA, Mundl H, Peacock WF, Czlonkowska A, Sharma M, Nolte CH, Shoamanesh A, Berkowitz SD, Krahn T, Endres M; NAVIGATE-ESUS Biomarker Working Group. High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source. Stroke. 2020 Aug;51(8):2386-2394. doi: 10.1161/STROKEAHA.120.029628. Epub 2020 Jul 9.

    PubMed 32640945

  • Veltkamp R, Pearce LA, Korompoki E, Sharma M, Kasner SE, Toni D, Ameriso SF, Mundl H, Tatlisumak T, Hankey GJ, Lindgren A, Berkowitz SD, Arauz A, Ozturk S, Muir KW, Chamorro A, Perera K, Shuaib A, Rudilosso S, Shoamanesh A, Connolly SJ, Hart RG. Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1233-1240. doi: 10.1001/jamaneurol.2020.1995.

    PubMed 32628266

  • Mikulik R, Eckstein J, Pearce LA, Mundl H, Rudilosso S, Olavarria VV, Shoamanesh A, Chamorro A, Marti-Fabregas J, Veltkamp R, Ozturk S, Tatlisumak T, Peacock WF, Berkowitz SD, Connolly SJ, Hart RG. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial. Stroke. 2020 Jul;51(7):2139-2147. doi: 10.1161/STROKEAHA.119.027995. Epub 2020 Jun 10.

    PubMed 32517582

  • Ntaios G, Pearce LA, Veltkamp R, Sharma M, Kasner SE, Korompoki E, Milionis H, Mundl H, Berkowitz SD, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial. Stroke. 2020 Jun;51(6):1797-1804. doi: 10.1161/STROKEAHA.119.028669. Epub 2020 Apr 16.

    PubMed 32295509

  • Martinez-Majander N, Ntaios G, Liu YY, Ylikotila P, Joensuu H, Saarinen J, Perera KS, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz SD, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner SE, Hart RG, Tatlisumak T; NAVIGATE ESUS investigators. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial. Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.

    PubMed 32056346

  • Ntaios G, Pearce LA, Meseguer E, Endres M, Amarenco P, Ozturk S, Lang W, Bornstein NM, Molina CA, Pagola J, Mundl H, Berkowitz SD, Liu YY, Sen S, Connolly SJ, Hart RG. Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial. Stroke. 2019 Nov;50(11):3184-3190. doi: 10.1161/STROKEAHA.119.025813. Epub 2019 Sep 17.

    PubMed 31526123

  • Ntaios G, Swaminathan B, Berkowitz SD, Gagliardi RJ, Lang W, Siegler JE, Lavados P, Mundl H, Bornstein N, Meseguer E, Amarenco P, Cucchiara B, Camps-Renom P, Makaritsis K, Korompoki E, Papavasileiou V, Marti-Fabregas J, Milionis H, Vemmos K, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis. Stroke. 2019 Sep;50(9):2477-2485. doi: 10.1161/STROKEAHA.119.025168. Epub 2019 Aug 12.

    PubMed 31401971

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Acetylsalicylic acid (Aspirin, BAY1019036) in people with Stroke, run by Bayer at 454 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 454 sites in Japan, United States, China, United Kingdom, Spain and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of the Composite Efficacy Outcome (Adjudicated) (time frame: From randomization until the efficacy cut-off date (median 326 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313909, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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