AzTrials
AzTrials

Moderate Risk of CVDPhase 3ARRIVENCT00501059

A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

A Phase 3 study testing Aspirin (Acetylsalicylic acid, BAYE4465) in people with Moderate Risk of CVD, run by Bayer at 466 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Moderate Risk of CVD
What is being tested?
Aspirin (Acetylsalicylic acid, BAYE4465)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,546 participants
Where
466 sitesin 8 countries
Study dates
5 Jul 2007to 15 Nov 2016
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
  • Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
  • Current smoking: defined as any cigarette smoking in the past 12 months
  • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
  • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
  • Currently on any medication to treat high blood pressure
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  • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
  • Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
  • Current smoking: defined as any cigarette smoking in the past 12 months
  • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
  • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
  • Currently on any medication to treat high blood pressure
  • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Who cannot join

  • History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
  • Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
  • Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
  • Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
  • Active diagnosed and documented reflux esophagitis
  • Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
Show all 15Show fewer
  • Lactating women or women of childbearing potential
  • Severe liver disease or damage based on the clinical judgment of the investigator
  • Severe renal disease or damage based on the clinical judgement of the investigator
  • A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
  • A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
  • Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
  • Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
  • Current use of an anticoagulant medication
  • Sitting systolic blood pressure greater than 170 mmHg

Trial locations and contacts

466 sites in 8 countries.

466 sites in 8 countries

United Kingdom137 sites

  • Study site

    Aberdeen, AB25 2ZD

  • Study site

    Addlestone, Surrey, KT15 2BH

  • Study site

    Airedire, ML66DB

  • Study site

    Annan, Dumfries And Galloway, DG12 6BG

  • Study site

    Antrim, North Ireland, BT36 4PP

  • Study site

    Antrim, North Ireland, BT37 9QN

  • Study site

    Antrim, North Ireland, BT41 3AE

  • Study site

    Antrim, BT38 9TG

  • Study site

    Ballymena, Antrim, BT42 4JP

  • Study site

    Ballymena, Antrim, BT43 6JD

  • Study site

    Bangor, Gwynedd, BT19 1PP

  • Study site

    Barry, SOuth Glamorgan, CF63 4HP

  • Study site

    Bath, Avon, BA2 3HT

  • Study site

    Bath, Avon, BA2 4BY

  • Study site

    Bath, Somerset, BA1 2SR

  • Study site

    Bath, BA11 2FH

  • Study site

    Bath, BA2 4JT

  • Study site

    Belfast, BT1 2JR

  • Study site

    Belfast, BT12 5EY

  • Study site

    Belfast, BT12 5LT

  • Study site

    Belfast, BT13 3BW

  • Study site

    Belfast, BT15 2GE

  • Study site

    Belfast, BT5 7BP

  • Study site

    Belfast, BT8 6GR

  • Study site

    Belfast

  • Study site

    Bellshill, ML4 1PS

  • Study site

    Bishop Auckland, Durham, DL14 6AB

  • Study site

    Blackpool, Lancashire, FY3 7EN

  • Study site

    Blackpool, Lancashire, FY4 3AD

  • Study site

    Blantyre, G72 0BS

  • Study site

    Bolton, Lancashire, BL3 6TL

  • Study site

    Bolton, Lancashire, BL5 3UB

  • Study site

    Boscastle, Cornwall, PL35 0BG

  • Study site

    Bradford on Avon, Wiltshire, BA15 1DQ

  • Study site

    Brighton, West Sussex, BN2 1ES

  • Study site

    Bury Saint Edmonds, Suffolk, IP30 9QU

  • Study site

    Bury St Edmunds, Suffolk, IP31 2HD

  • Study site

    Bury St Edmunds, Suffolk, IP32 7EW

  • Study site

    Canterbury, Kent, CT1 3HX

  • Study site

    Cardiff, CF5 4AD

  • Study site

    Carryduff, Down, BT8 8HR

  • Study site

    Carstairs, Lanarkshire, ML11 8QD

  • Study site

    Chapelhall, Stratchclyde, ML6 8SR

  • Study site

    Chesterfield, Derbyshire, S40 4AA

  • Study site

    Chestfield, Kent, CT5 3QU

  • Study site

    Chippenham, Wiltshire, SN14 6GT

  • Study site

    Chippenham, Wiltshire, SN15 2SB

  • Study site

    Chipping Norton, Oxfordshire, OX75FA

  • Study site

    Coatbridge, Lanarkshire, ML5 3AP

  • Study site

    Coatrbridge, ML5 3BJ

  • Study site

    Corsham, Wiltshire, SN3 9DL

  • Study site

    Coventry, Warwickshire, CV6 4DD

  • Study site

    Coventry, Warwickshire, CV7 8LA

  • Study site

    Coventry, West Midlands, CV9 1EU

  • Study site

    Craigavon, Armagh, BT67 0LQ

  • Study site

    Crawley, West Sussex, RH10 1LL

  • Study site

    Crawley, West Sussex, RH10 7DX

  • Study site

    Crossgar, BT30 9JU

  • Study site

    Crumlin, Antrim, BT29 4LP

  • Study site

    Darlington, Durham, DL2 1AA

  • Study site

    Darlington, Durham, DL3 7JR

  • Study site

    Darlington, Durham, DL3 8SQ

  • Study site

    Doncaster, South Yorkshire, DN1 2ET

  • Study site

    Doncaster, DN1 2EU

  • Study site

    Dronfield, Derbyshire, S18 8QY

  • Study site

    Dundee, DD19SY

  • Study site

    East Horsley, Surrey, KT24 6QT

  • Study site

    Eccles, Sheffield, S35 9XQ

  • Study site

    Ely, Cambridgeshire, CB7 4HF

  • Study site

    Ely, Cambridgeshire, CB7 5SQ

  • Study site

    Forth, Lanarkshire, ML1 8AJ

  • Study site

    Fowey, Cornwall, PL23 1DT

  • Study site

    Glasgow, Glasgow City, G20 0XA

  • Study site

    Glasgow, Stratchclyde, G45 9AW

  • Study site

    Glasgow, G21 1TR

  • Study site

    Glasgow, G5 0BQ

  • Study site

    Glasgow, G52 3QN

  • Study site

    Glasgow, G67 1BJ

  • Study site

    Hadleigh, Suffolk, IP7 5DN

  • Study site

    Hamilton, Stratchclyde, ML3 ODR

  • Study site

    Hamilton, ML3 7EN

  • Study site

    Hamilton, ML3 8AA

  • Study site

    High Valleyfield, Fife, KY12 8SJ

  • Study site

    Hinckley, Leicestershire, LE10 2SE

  • Study site

    Hitchin, Hertfordshire, SG4 9TH

  • Study site

    Inverness, IV2 4AG

  • Study site

    Ipswich, IP4 2PU

  • Study site

    Irvine, Ayrshire, KA12 0AY

  • Study site

    Johnstone, Stratchclyde, PA5 8EY

  • Study site

    Leeds, West Yorkshire, LS10 3NB

  • Study site

    Leeds, West Yorkshire, LS118BS

  • Study site

    Leeds, West Yorkshire, LS15 9JH

  • Study site

    Leeds, West Yorkshire, LS25 1AN

  • Study site

    Leeds, West Yorkshire, LS25 1HB

  • Study site

    Leeds, West Yorkshire, LS25 7AB

  • Study site

    Leeds, West Yorkshire, LS26 8SZ

  • Study site

    Leeds, West Yorkshire, LS9 9EF

  • Study site

    Leigh-on-Sea, Essex, SS9 2SQ

  • Study site

    Letchworth Garden City, Hertfordshire, SG6 4TS

  • Study site

    Letchworth Garden City, Hertfordshire, SG6 4UB

  • Study site

    Lockerbie, D11 2BJ

  • Study site

    London, SW12 8EU

  • Study site

    Luton, Bedfordshire, LU2 9SB

  • Study site

    Manchester, M13 9WL

  • Study site

    Motherwell, Stratchclyde, ML1 3JX

  • Study site

    New Stevenson, ML1 4LT

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE15 6TQ

  • Study site

    Newtonabbey, Antrim, BT37 9QU

  • Study site

    Paisley

  • Study site

    Penzance, Cornwall, TR18 4EL

  • Study site

    Penzance, Cornwall, TR18 4JH

  • Study site

    Penzance, Cornwall, TR19 7HX

  • Study site

    Peterborough, Cambridgeshire, PE2 5GP

  • Study site

    Peterborough, Cambridgeshire, PE7 3JL

  • Study site

    Peterborough, PE8 6PL

  • Study site

    Plymouth, Devon, PL6 7TH

  • Study site

    Radstock, Avon, BA3 2UH

  • Study site

    Rugby, Warwickshire, CV21 3SP

  • Study site

    Saltash, Cornwall, PL12 6DL

  • Study site

    Sandbach, Cheshire, CW11 1EQ

  • Study site

    Sheffield, South Yorkshire, S7 2DW

  • Study site

    Slough, Berkshire, SL1 1TT

  • Study site

    St Austell, Cornwall, PL26 7RL

  • Study site

    Stowmarket, Suffolk, IP14 1NL

  • Study site

    Thornhill, DG3 5AA

  • Study site

    Tiptree, Essex, CO5 0HB

  • Study site

    Trowbridge, Wiltshire, BA14 9AR

  • Study site

    Tyrone, North Ireland, BT80 8BG

  • Study site

    Watford, WD25 7NL

  • Study site

    Wellingborough, Northamptonshire, NN8 4RW

  • Study site

    Wells-next-the-Sea, Norfolk, NR23 1JP

  • Study site

    Westbury, Wiltshire, BA13 3FQ

  • Study site

    Whitstable, Kent, CT5 3SE

  • Study site

    Wishaw, ML2 7BQ

  • Study site

    Witley Bay, NE26 1NA

  • Study site

    Worcester Park, Surrey, KT4 7BX

  • Study site

    Wymondham, Norfolk, NR18 0RF

Other trials in United Kingdom

Germany136 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Aachen, North Rhine-Westphalia, 52080

  • Study site

    Apolda, Thuringia, 99510

  • Study site

    Arnsberg, North Rhine-Westphalia, 59757

  • Study site

    Arzberg, Bavaria, 95659

  • Study site

    Aurich, Lower Saxony, 26603

  • Study site

    Bad Bramstedt, Schleswig-Holstein, 24576

  • Study site

    Bad Lippspringe, North Rhine-Westphalia, 33175

  • Study site

    Bad Salzuflen, North Rhine-Westphalia, 32105

  • Study site

    Bad Salzuflen, North Rhine-Westphalia, 32108

  • Study site

    Bad Sassendorf, North Rhine-Westphalia, 59505

  • Study site

    Benningen am Neckar, Baden-Wurttemberg, 71726

  • Study site

    Bergkamen, North Rhine-Westphalia, 59192

  • Study site

    Bergrheinfeld, Bavaria, 97493

  • Study site

    Berlin, 10249

  • Study site

    Berlin, 10407

  • Study site

    Berlin, 12099

  • Study site

    Berlin, 13055

  • Study site

    Berlin, 13057

  • Study site

    Berlin, 13405

  • Study site

    Berlin, 13467

  • Study site

    Berlin, 14050

  • Study site

    Beucha, Saxony, 04824

  • Study site

    Bitterfeld-Wolfen, Saxony-Anhalt, 06749

  • Study site

    Blankenhain, Thuringia, 99444

  • Study site

    Bochum, North Rhine-Westphalia, 44797

  • Study site

    Bockenem, Lower Saxony, 31167

  • Study site

    Borna, Saxony, 04552

  • Study site

    Braunschweig, Lower Saxony, 38100

  • Study site

    Cologne, North Rhine-Westphalia, 51069

  • Study site

    Cottbus, Brandenburg, 03046

  • Study site

    Daaden, 57567

  • Study site

    Deggingen, Baden-Wurttemberg, 73326

  • Study site

    Delitzsch, Saxony, 04509

  • Study site

    Dinkelsbühl, Bavaria, 91550

  • Study site

    Dortmund, North Rhine-Westphalia, 44139

  • Study site

    Dortmund, North Rhine-Westphalia, 44328

  • Study site

    Dortmund, North Rhine-Westphalia, 44339

  • Study site

    Dossenheim, Baden-Wurttemberg, 69221

  • Study site

    Dresden, Saxony, 01069

  • Study site

    Dresden, Saxony, 01127

  • Study site

    Dresden, Saxony, 01277

  • Study site

    Duisburg, North Rhine-Westphalia, 47199

  • Study site

    Elsterwerda, Brandenburg, 04910

  • Study site

    Essen, North Rhine-Westphalia, 45130

  • Study site

    Essen, North Rhine-Westphalia, 45136

  • Study site

    Essen, North Rhine-Westphalia, 45276

  • Study site

    Essen, North Rhine-Westphalia, 45355

  • Study site

    Essen, North Rhine-Westphalia, 45359

  • Study site

    Ettlingen, Baden-Wurttemberg, 78275

  • Study site

    Frankfurt am Main, Hesse, 60599

  • Study site

    Frankfurt am Main, Hesse, 65929

  • Study site

    Freudenberg, North Rhine-Westphalia, 57258

  • Study site

    Gars, Bavaria, 83536

  • Study site

    Graben-Neudorf, Baden-Wurttemberg, 76676

  • Study site

    Gransee, Brandenburg, 16775

  • Study site

    Greven, North Rhine-Westphalia, 48268

  • Study site

    Grimma, Thuringia, 04668

  • Study site

    Halle, Saxony-Anhalt, 06124

  • Study site

    Hamburg, 22041

  • Study site

    Hamburg, 22143

  • Study site

    Hamburg, 22177

  • Study site

    Hamburg, 22299

  • Study site

    Hamburg, 22335

  • Study site

    Hamm, North Rhine-Westphalia, 59069

  • Study site

    Hanau, Hesse, 63450

  • Study site

    Heilbronn, Baden-Wurttemberg, 74080

  • Study site

    Hockenheim, Baden-Wurttemberg, 68766

  • Study site

    Hohenau, Bavaria, 94545

  • Study site

    Horneburg, Lower Saxony, 21640

  • Study site

    Hünxe, North Rhine-Westphalia, 46569

  • Study site

    Jühnde, Lower Saxony, 37127

  • Study site

    Kallstadt, Rhineland-Palatinate, 67169

  • Study site

    Kamp-Lintfort, North Rhine-Westphalia, 47475

  • Study site

    Kelkheim, Hesse, 65779

  • Study site

    Ketzin, Brandenburg, 14669

  • Study site

    Krefeld, North Rhine-Westphalia, 47798

  • Study site

    Künzing, Bavaria, 94550

  • Study site

    Langenfeld, North Rhine-Westphalia, 40764

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Leipzig, Saxony, 04249

  • Study site

    Lienen, North Rhine-Westphalia, 49536

  • Study site

    Lippetal, North Rhine-Westphalia, 59510

  • Study site

    Löhne, North Rhine-Westphalia, 32584

  • Study site

    Loxstedt, Lower Saxony, 27612

  • Study site

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Study site

    Magdeburg, Saxony-Anhalt, 39104

  • Study site

    Mainz, Rhineland-Palatinate, 55116

  • Study site

    Mainz, Rhineland-Palatinate, 55127

  • Study site

    Markkleeberg, Saxony, 04416

  • Study site

    Marl, North Rhine-Westphalia, 45770

  • Study site

    Meissen, Saxony, 01662

  • Study site

    München, Bavaria, 80336

  • Study site

    Münster, North Rhine-Westphalia, 48167

  • Study site

    Nassau, Rhineland-Palatinate, 56377

  • Study site

    Netphen, North Rhine-Westphalia, 57250

  • Study site

    Nienburg, Lower Saxony, 31582

  • Study site

    Northeim, Lower Saxony, 37154

  • Study site

    Oberaurach, Bavaria, 97514

  • Study site

    Oberwiesenthal, Saxony, 09484

  • Study site

    Papenburg, Lower Saxony, 26871

  • Study site

    Porta Westfalica, North Rhine-Westphalia, 32457

  • Study site

    Potsdam, Brandenburg, 14778

  • Study site

    Rehburg-Loccum, 31547

  • Study site

    Reinfeld, Schleswig-Holstein, 23858

  • Study site

    Remscheid, North Rhine-Westphalia, 42897

  • Study site

    Rhaunen, Rhineland-Palatinate, 55624

  • Study site

    Riede, 27339

  • Study site

    Riesa, Saxony, 01587

  • Study site

    Rotenburg an der Fulda, Hesse, 36199

  • Study site

    Sand Am Main, Bavaria, 97522

  • Study site

    Schrobenhausen, Bavaria, 86529

  • Study site

    Schwetzingen, Baden-Wurttemberg, 68723

  • Study site

    Siegen, North Rhine-Westphalia, 57072

  • Study site

    Sinzheim, Baden-Wurttemberg, 76547

  • Study site

    Spalt, Bavaria, 91174

  • Study site

    Speyer, Rhineland-Palatinate, 67346

  • Study site

    Stockach, Baden-Wurttemberg, 78333

  • Study site

    Straßkirchen, Bavaria, 94342

  • Study site

    Stuhr, Lower Saxony, 28816

  • Study site

    Stuttgart, Baden-Wurttemberg, 70378

  • Study site

    Sulzbach-Rosenberg, Bavaria, 92237

  • Study site

    Thedinghausen, 27321

  • Study site

    Trossingen, Baden-Wurttemberg, 78647

  • Study site

    Ursensollen, Bavaria, 92289

  • Study site

    Viersen, North Rhine-Westphalia, 41751

  • Study site

    Wardenburg, Lower Saxony, 26203

  • Study site

    Weinheim, Baden-Wurttemberg, 69469

  • Study site

    Welver, North Rhine-Westphalia, 59514

  • Study site

    Wermsdorf, Saxony, 04779

  • Study site

    Wetter, Hesse, 35083

  • Study site

    Wetter, North Rhine-Westphalia, 58300

  • Study site

    Weyhe, Lower Saxony, 28844

  • Study site

    Winsen, Lower Saxony, 21423

  • Study site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

United States73 sites

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Belvidere, New Jersey, 07823

  • Study site

    Birmingham, Alabama, 39294

  • Medical Research Trust

    Boynton Beach, Florida, 33426

  • Study site

    Bridgman, Michigan, 49106

  • Study site

    Broken Bow, Nebraska, 68822

  • Study site

    Burlington, North Carolina, 27215

  • Study site

    Cadillac, Michigan, 49601

  • Study site

    Carlisle, Ohio, 45005-3320

  • Study site

    Cherry Hill, New Jersey, 08084

  • Study site

    Chicago, Illinois, 60628

  • Study site

    Chicago, Illinois, 60631-1958

  • Study site

    Clifton, New Jersey, 07013

  • Study site

    Columbus, North Carolina, 28722

  • Study site

    Daingerfield, Texas, 75638

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Fremont, California, 94536-3702

  • Study site

    Gainesville, Florida, 32601

  • Study site

    Graysville, Alabama, 35073

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Hainesport, New Jersey, 08036

  • Study site

    Hialeah, Florida, 33016

  • Medical Research Centers of South Florida, Inc.

    Hollywood, Florida, 33021

  • Office of Dr.Larry Levinson, DO

    Hollywood, Florida, 33021

  • Study site

    Honaker, Virginia, 24260

  • Study site

    Hot Springs, Arkansas, 71913-4457

  • Study site

    Huntington Park, California, 90255

  • Study site

    Interlochen, Michigan, 49643-9264

  • Study site

    Jersey City, New Jersey, 07306

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Largo, Florida, 33770

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Lebanon, Kentucky, 40033

  • Study site

    Linden, New Jersey, 07036

  • Study site

    Lockport, Illinois, 60491

  • Study site

    Los Angeles, California, 90025

  • Study site

    Marianna, Florida, 32446-2120

  • Study site

    Marion, Ohio, 43302

  • Study site

    McKinney, Texas, 75069

  • Study site

    Montgomery, Ohio, 45242

  • Study site

    Newark, Delaware, 19702

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68116-2004

  • Study site

    Panama City, Florida, 32401

  • Study site

    Pell City, Alabama, 35125

  • Study site

    Perrysburg, Ohio, 43551

  • PharmaTrials, Inc.

    Perth Amboy, New Jersey, 08861

  • Study site

    Phoenix, Arizona, 85051

  • Study site

    Port Gibson, Mississippi, 39150

  • Study site

    Prince Frederick, Maryland, 20678

  • Tallahassee Memorial Family

    Quincy, Florida, 32351

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Rancho Cucamonga, California, 91730

  • Merit Medical Group, Inc.

    Richlands, Virginia, 24641-2067

  • Study site

    Rockwall, Texas, 75032

  • Study site

    Rolling Hills Estates, California, 90274

  • Study site

    San Antonio, Texas, 78205-1116

  • Study site

    San Marcos, Texas, 78666

  • Helping Hands Clinical Trials

    Santa Ana, California, 92704

  • Study site

    Scottsdale, Arizona, 85260

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Stephenville, Texas, 76401

  • Study site

    Stratford, New Jersey, 08084

  • Study site

    Sugar Land, Texas, 77478

  • Study site

    Tampa, Florida, 33614

  • Study site

    Taylors, South Carolina, 29687

  • Study site

    Troy, Michigan, 48085

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Vernon Hills, Illinois, 60061

Other trials in United States

Poland50 sites

  • Study site

    Bialystok, 15-183

  • Study site

    Bydgoszcz, 85-863

  • Study site

    Bydgoszcz

  • Study site

    Chrzanów

  • Study site

    Czechowice-Dziedzice

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80-286

  • Study site

    Gdansk, 80-461

  • Study site

    Gdansk, 80-822

  • Study site

    Gdynia, 81-317

  • Study site

    Gliwice, 44-109

  • Study site

    Grodzisk Mazowiecki, 05-825

  • Study site

    Katowice, 40-226

  • Study site

    Katowice, 40-752

  • Study site

    Krakow, 30-424

  • Study site

    Krakow, 31-011

  • Study site

    Krakow, 31-156

  • Study site

    Krakow, 31-567

  • Study site

    Krakow, 31-637

  • Study site

    Krakow

  • Study site

    Kutno, 99-300

  • Study site

    Łańcut

  • Study site

    Linia, 84-223

  • Study site

    Lodz

  • Study site

    Lublin, 20-044

  • Study site

    Lublin, 20-258

  • Study site

    Lublin

  • Study site

    Małaszewicze

  • Study site

    Malbork, 82-200

  • Study site

    Nakło nad Notecią, 98-100

  • Study site

    Olkusz

  • Study site

    Ostrów Wielkopolski, 63-400

  • Study site

    Poznan, 60-539

  • Study site

    Przeworsk, 37-200

  • Study site

    Radom, 26-600

  • Study site

    Skierniewice, 96-100

  • Study site

    Skierniewice

  • Study site

    Sobótka

  • Study site

    Sopot, 81-746

  • Study site

    Szczyrk, 43-370

  • Study site

    Wąbrzeźno

  • Study site

    Warsaw, 01-192

  • Study site

    Warsaw, 02-507

  • Study site

    Warsaw, 02-796

  • Study site

    Wejherowo

  • Study site

    Włocławek

  • Study site

    Wola

  • Study site

    Wroclaw, 50-127

  • Study site

    Wroclaw, 51-112

  • Study site

    Zabrze

Other trials in Poland

Spain36 sites

  • Study site

    Albacete, 2260

  • Study site

    Alcover, Tarragona, 43460

  • Study site

    Alicante, 03007

  • Study site

    Badajoz, 06140

  • Study site

    Barcelona, 08017

  • Study site

    Barcelona, 08023

  • Study site

    Barcelona, 08025

  • Study site

    Begonte, Lugo, 27373

  • Study site

    Benidorm, Alicante, 03503

  • Study site

    Elche, Alicante

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    Espinardo, Murcia, 30100

  • Study site

    Gümar, Santa Cruz De Tenerife, 38591

  • Study site

    Huelva, 21003

  • Study site

    La Roda, Albacete, 06230

  • Study site

    La Victoria, Santa Cruz De Tenerife, 38380

  • Study site

    León, 24001

  • Study site

    León

  • Study site

    Lugo, 27770

  • Study site

    Madrid, 28003

  • Study site

    Madrid, 28030

  • Study site

    Madrid, 28032

  • Study site

    Murcia, 300005

  • Study site

    Murcia, 30007

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    Murcia, 30008

  • Study site

    Ourense, Ourense, 32003

  • Study site

    Oviedo, Principality of Asturias, 33009

  • Study site

    Oviedo, Principality of Asturias, 33013

  • Study site

    Petrel, Alicante, 03610

  • Study site

    Posada de Llanes, Principality of Asturias, 33594

  • Study site

    Salamanca, 27-31

  • Study site

    Santander, 39009

  • Study site

    Sobrado Dos Monxes, A Coruña, 15813

  • Study site

    Valladolid, 47007

  • Study site

    Vic (Barcelona), Catalonia, 08500

  • Study site

    Viveiro, Lugo, 27850

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    Xixona, Alicante, 03100

Other trials in Spain

Italy20 sites

  • Study site

    Amandola, Ascoli Piceno, 63021

  • Study site

    Asti, 14100

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    Bergamo, 24128

  • Study site

    Catania, Sicily, 95124

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    Chiavari, Genova, 16043

  • Study site

    Chieri, Torino, 10023

  • Study site

    Chieti, Abruzzo, 66100

  • Study site

    Como, Lombardy, 22066

  • Study site

    Foggia, Apulia, 71100

  • Study site

    Grosseto, Tuscany, 58100

  • Study site

    Legnano, Milano, 20025

  • Study site

    Moncalieri, Torino, 10024

  • Study site

    Naples, Campania, 80131

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    Novara, Piedmont, 28100

  • Study site

    Reggio Emilia, Emilia-Romagna, 42019

  • Study site

    Reggio Emilia, 42123

  • Study site

    Rome, Lazio, 00157

  • Study site

    Rome, Lazio, 00161

  • Study site

    Turin, Piedmont, 10023

  • Study site

    Varese, Lombardy, 21100

Other trials in Italy

Ireland9 sites

  • Study site

    Bishopstown, Cork

  • Study site

    Bray, Wicklow

  • Study site

    Cork

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    Dublin, 2

  • Study site

    Enniscorthy, Wexford

  • Study site

    Gorey, Wexford

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    Kilmallock, Limerick

  • Study site

    Rathkeale, Limerick

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    Tallow, Waterford

Other trials in Ireland

Puerto Rico5 sites

  • Study site

    Guaynabo, 00968

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Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Read the detailed description

Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

  • Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
  • Exclusion of patients currently taking anticoagulant medication
  • A longer interval between the daily dose of study drug and ibuprofen
  • Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

  • Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

  • The primary endpoint is changed to include confirmed UA and TIA.
  • The estimated event rate is changed to 1.5% per year due to new information.
  • Effect size (risk reduction) changed from 14.9% to 17 to 18%.
  • Achieving 60,000 person-years instead of 1488 primary endpoint events
  • Additional treatment and follow-up for a maximum of another 12 months.
  • Change to reduced adverse event and concomitant therapy reporting
Being tested
Aspirin (Acetylsalicylic acid, BAYE4465), Placebo
Keywords
Primary prevention of coronary heart disease, Stroke and cardiovascular death, Aspirin
Medical subject headings
Stroke

What participants receive

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

  • Aspirin (Acetylsalicylic acid, BAYE4465)Drug

    100mg enteric coated Aspirin, taken daily

  • PlaceboDrug

    Placebo, taken daily

Study groups in NCT00501059
Study groupRoleWhat they receive
Acetylsalicylic acid (Aspirin, BAYE4465)ExperimentalParticipants received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
Receives: Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
PlaceboPlacebo comparatorParticipants received 1 tablets of matching placebo orally once daily.
Receives: Drug: Placebo

What is being measured

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

  1. Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)

    The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

    Measured: Until follow-up (approximate 6 years)

Secondary outcomes (5)

  1. Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)

    The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

    Measured: Until follow-up (approximate 6 years)

  2. Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA

    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

    Measured: Until follow-up (approximately 6 years)

  3. Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer

    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

    Measured: Until follow-up (approximately 6 years)

  4. Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer

    Measured: Until follow-up (approximately 6 years)

  5. Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately

    The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. *all other CV death without fatal MI and fatal stroke

    Measured: Until follow-up (approximately 6 years)

Timeline

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

  1. First posted13 Jul 2007 (estimated)
  2. Study start5 Jul 2007
  3. Primary completion15 Nov 2016
  4. Study completion15 Nov 2016

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
12,546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00501059
Sponsor's protocol ID
12198
Other IDs
2006-003622-29
Acronym
ARRIVE
Status last verified
Sep 2018
First submitted
12 Jul 2007
Last updated
26 Oct 2018
Data monitoring committee
Yes

Publications

  • Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.

    PubMed 30158069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aspirin (Acetylsalicylic acid, BAYE4465) in people with Moderate Risk of CVD, run by Bayer at 466 sites in 8 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 15 inclusion and 15 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: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 466 sites in United Kingdom, Germany, United States, Poland, Spain and 3 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. Some participants in this study may receive a placebo. 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 8 Jan 2018). 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?

Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) (time frame: Until follow-up (approximate 6 years)). 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 NCT00501059, which also lists 1 linked publication.

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 26 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.

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