AzTrials
AzTrials

Acute Coronary SyndromePhase 4FUTURA/OASIS 8NCT00790907

Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)

A Phase 4 study testing fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin and Open label fondaparinux in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 203 sites in 18 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin and Open label fondaparinux
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,235 participants
Where
203 sitesin 18 countries
Study dates
Feb 2009to May 2010
Phase
Phase 4
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitro-glycerine for relief of the pain).
  • Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms.
  • Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
  • At least two of the three following additional criteria:
  • Age greater than or equal to 60 years
  • Troponin T or I or CK-MB above the upper limit of normal for the local institution;
  • Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation.
  • Written informed consent dated and signed

Who cannot join

  • Age < 21 years.
  • Any contraindication to UFH or fondaparinux
  • Contraindication for angiography or PCI at baseline
  • Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with:
  • refractory or recurrent angina associated with dynamic ST-deviation
  • heart failure
Show all 22Show fewer
  • life-threatening arrhythmias
  • hemodynamic instability
  • Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (intravenous(i.v.) or s.c.) dose was:
  • ≥ 8 hours for low molecular weight heparin (LMWH)
  • ≥60 minutes for bivalirudin
  • ≥90 minutes for unfractionated heparin (UFH)
  • Hemorrhagic stroke within the last 12 months.
  • Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
  • Pregnancy or women of childbearing potential who are not using an effective method of contraception.
  • Co-morbid condition with life expectancy less than 6 months.
  • Currently receiving an experimental pharmacological agent.
  • Revascularization procedure already performed for the qualifying event.
  • Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
  • Following angiography and confirmation that the subject is to undergo PCI, the subject must also meet all of the following additional criteria in order to be randomised:
  • Subjects will have received at least 1 dose of open-label fondaparinux
  • The most recent dose of open-label fondaparinux will not have been more than 24 hours before the start of the PCI procedure.

Trial locations and contacts

203 sites in 18 countries.

203 sites in 18 countries

Germany35 sites

  • GSK Investigational Site

    Bad Rothenfelde, Lower Saxony, 49214

  • GSK Investigational Site

    Bad Tölz, Bavaria, 83646

  • GSK Investigational Site

    Berlin, State of Berlin, 10249

  • GSK Investigational Site

    Berlin, State of Berlin, 12683

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Bernau bei Berlin, Brandenburg, 16321

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Bremen, Free Hanseatic City of Bremen, 28277

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • GSK Investigational Site

    Cottbus, Brandenburg, 03048

  • GSK Investigational Site

    Dachau, Bavaria, 85221

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Erfurt, Thuringia, 99089

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22527

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Heidenheim, Baden-Wurttemberg, 89522

  • GSK Investigational Site

    Herford, North Rhine-Westphalia, 32049

  • GSK Investigational Site

    Homburg, Saarland, 66421

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Langen, Hesse, 63225

  • GSK Investigational Site

    Leipzig, Saxony, 04289

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • GSK Investigational Site

    Neumünster, Schleswig-Holstein, 24534

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41464

  • GSK Investigational Site

    Quedlinburg, Saxony-Anhalt, 06484

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Rüsselsheim am Main, Hesse, 65428

  • GSK Investigational Site

    Simbach A. Inn, Bavaria, 84359

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

Poland17 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Bytom, 41-902

  • GSK Investigational Site

    Częstochowa, 42-200

  • GSK Investigational Site

    Dąbrowa Górnicza, 41-300

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Gdynia, 81-348

  • GSK Investigational Site

    Koszalin, 75-581

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Krakow, 31-501

  • GSK Investigational Site

    Lubin, 59-301

  • GSK Investigational Site

    Radom, 26-617

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Wałbrzych, 58-309

  • GSK Investigational Site

    Warsaw, 02-637

  • GSK Investigational Site

    Warsaw, 04-073

  • GSK Investigational Site

    Włocławek, 87-800

  • GSK Investigational Site

    Wroclaw, 51-124

Other trials in Poland

India15 sites

  • GSK Investigational Site

    Ahmedabad, 380015

  • GSK Investigational Site

    Ahmedabad, 380052

  • GSK Investigational Site

    Ahmedabad, 380054

  • GSK Investigational Site

    Bandra, Mumbai, 400050

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Dhantoli, Nagpur, 440012

  • GSK Investigational Site

    Dhantoli, Nagpur

  • GSK Investigational Site

    Jaipur, 302001

  • GSK Investigational Site

    Lucknow, 226014

  • GSK Investigational Site

    New Delhi, 110017

  • GSK Investigational Site

    New Delhi, 110060

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Pune, 411030

  • GSK Investigational Site

    Secunderabad, 500003

  • GSK Investigational Site

    Vadodara, 390015

Other trials in India

Russia14 sites

  • GSK Investigational Site

    Barnaul, 656055

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Krasnodar, 350086

  • GSK Investigational Site

    Moscow, 109240

  • GSK Investigational Site

    Moscow, 111539

  • GSK Investigational Site

    Moscow, 121359

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Novosibirsk, 630055

  • GSK Investigational Site

    Perm, 614107

  • GSK Investigational Site

    Saint Petersburg, 195067

  • GSK Investigational Site

    St'Petersburg, 194156

  • GSK Investigational Site

    Tomsk, 634012

  • GSK Investigational Site

    Voronezh, 394066

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Argentina13 sites

  • GSK Investigational Site

    Adrogué, Buenos Aires, B1846DSK

  • GSK Investigational Site

    Bahía Blanca, Buenos Aires, 8001

  • GSK Investigational Site

    Buenos Aires, 1428

  • GSK Investigational Site

    Corrientes, Corrientes Province, W3400AMZ

  • GSK Investigational Site

    La Plata, Buenos Aires, B1900AXI

  • GSK Investigational Site

    Merlo, Buenos Aires, B1722COV

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878CBI

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878DFK

  • GSK Investigational Site

    Rosario, Buenos Aires, S2000CHT

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DSR

  • GSK Investigational Site

    San Miguel de Tucumán, T4000NIL

  • GSK Investigational Site

    Santa Fe, Santa Fe Province, S3000AZG

  • GSK Investigational Site

    Santa Fe, Santa Fe Province, S3000FUJ

Other trials in Argentina

South Korea13 sites

  • GSK Investigational Site

    Busan, 602-715

  • GSK Investigational Site

    Daejeon, 302-718

  • GSK Investigational Site

    Gangnam-gu, Seoul, 135-710

  • GSK Investigational Site

    Goyang-si, Gyeonggi-do, 411-773

  • GSK Investigational Site

    Gwangju, 501-717

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Gyeonggi-do

  • GSK Investigational Site

    Jeonju-si, Jeollabuk-Do, 561-712

  • GSK Investigational Site

    Seoul, 134-090

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Seoul, 158-710

  • GSK Investigational Site

    Seoul

Other trials in South Korea

Spain13 sites

  • GSK Investigational Site

    Alicante, 03010

  • GSK Investigational Site

    Galdakao, 48960

  • GSK Investigational Site

    León, 24071

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Vigo/Pontevedra, 36200

Other trials in Spain

Italy12 sites

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40133

  • GSK Investigational Site

    Cremona, Lombardy, 26100

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Lucca, Tuscany, 55100

  • GSK Investigational Site

    Mantua, Lombardy, 46100

  • GSK Investigational Site

    Milan, Lombardy, 20138

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Pavia, Lombardy, 27100

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Rozzano (Mi), Lombardy, 20089

  • GSK Investigational Site

    Sassari, Sardinia, 07100

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Brazil10 sites

  • GSK Investigational Site

    Blumenau, Santa Catarina, 89010-906

  • GSK Investigational Site

    Campina Grande do Sul, Paraná, 83430000

  • GSK Investigational Site

    Campinas, São Paulo, 13059740

  • GSK Investigational Site

    Curitiba, Paraná, 80320320

  • GSK Investigational Site

    Marília, São Paulo, 17515-900

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90620001

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15015210

  • GSK Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

France10 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Dijon, 21079

  • GSK Investigational Site

    Marseille, 13385

  • GSK Investigational Site

    Montfermeil, 93370

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Rouen, 76031

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37044

Other trials in France

Canada9 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 2T9

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 5H6

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    London, Ontario, N6A 5A5

  • GSK Investigational Site

    Montreal, Quebec, H1T 1C8

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Czechia9 sites

  • GSK Investigational Site

    Brno, 656 91

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Karlovy Vary, 360 66

  • GSK Investigational Site

    Pilsen, 304 60

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 128 00

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Ústí nad Labem, 400 11

  • GSK Investigational Site

    Zlín, 762 75

Other trials in Czechia

Hungary8 sites

  • GSK Investigational Site

    Balatonfüred, 8230

  • GSK Investigational Site

    Budapest, 1096

  • GSK Investigational Site

    Budapest, 1106

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Miskolc, 3526

  • GSK Investigational Site

    Pécs, 7624

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Greece7 sites

  • GSK Investigational Site

    Athens, 115 26

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 124 62

  • GSK Investigational Site

    Athens, 151 27

  • GSK Investigational Site

    Athens, 176 74

  • GSK Investigational Site

    Ioannina, 45 500

  • GSK Investigational Site

    Rio- Patras, 26 504

Other trials in Greece

United Kingdom6 sites

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Bristol, BS2 8HW

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Edinburgh, EH16 4SA

  • GSK Investigational Site

    Southampton

  • GSK Investigational Site

    Tooting, London, SW17 0QT

Other trials in United Kingdom

Bulgaria5 sites

  • GSK Investigational Site

    Plovdiv, 4002

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1309

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1709

Other trials in Bulgaria

United States4 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87106

  • GSK Investigational Site

    Dallas, Texas, 75216

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Syracuse, New York, 13210

Other trials in United States

Netherlands3 sites

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Rotterdam, 3075 EA

Other trials in Netherlands

About this study

Official title: FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction (UA/NSTEMI) Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography (OASIS 8)

The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

Read the detailed description

Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo angiography (ideally within 72 hours) will be assessed for eligibility and consented. Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5 milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated for PCI and meeting the additional requirements for randomization will be randomised to receive one of two dose regimens of UFH either standard dose or low dose immediately prior to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at the investigator's discretion for up to a maximum of 8 days or hospital discharge, whichever is earlier.

Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once daily for up to 8 days or hospital discharge, whichever is earlier.

All subjects will be followed up for 30 days after randomization/angiography.

Being tested
fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin, Open label fondaparinux
Keywords
Unstable angina, Non ST elevation myocardial infarction, PCI, unfractionated heparin, fondaparinux, acute coronary syndrome
Medical subject headings
Acute Coronary Syndrome, Angina, Unstable, Non-ST Elevated Myocardial Infarction

What participants receive

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

  • fondaparinux background and standard dose UFHDrug

    Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein [GP] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

  • Fondaparinux background and low dose heparinDrug

    Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose UFH (50 U/kg), which was not adjusted for planned GPIIb/IIIa inhibitor use or ACT). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

  • Open label fondaparinuxDrug

    Open-label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for PCI and not randomized

Study groups in NCT00790907
Study groupRoleWhat they receive
Open label fondaparinux background and standard dose UFHExperimentalSubjects indicated for PCI and randomized to receive standard dose UFH
Receives: Drug: fondaparinux background and standard dose UFH
Open label fondaparinux background and low dose UFHExperimentalSubjects indicated for PCI and randomized to receive low dose UFH
Receives: Drug: Fondaparinux background and low dose heparin
Open label fondapaparinuxOtherSubjects not indicated for PCI and not randomized
Receives: Drug: Open label fondaparinux

What is being measured

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

  1. Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period

    The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.

    Measured: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Secondary outcomes (7)

  1. Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.

    Measured: Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR

  2. Number of Participants With Major Bleeding During the Peri-PCI Period

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.

    Measured: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

  3. Number of Participants With Minor Bleeding During the Peri-PCI Period

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.

    Measured: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

  4. Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.

    Measured: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

  5. Number of Participants With Major PCI-related Procedural Complications

    Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.

    Measured: During PCI procedure: immediately after randomization (approximately 10-75 minutes)

  6. Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.

    Measured: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

  7. Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30

    The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.

    Measured: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

Timeline

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

  1. First posted14 Nov 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790907
Sponsor's protocol ID
108888
Acronym
FUTURA/OASIS 8
Status last verified
Mar 2017
First submitted
13 Nov 2008
Last updated
23 Mar 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • FUTURA/OASIS-8 Trial Group; Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.

    PubMed 20805623

  • Ducrocq G, Jolly S, Mehta SR, Rao SV, Patel T, Moreno R, Gao P, Steg PG. Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002044. doi: 10.1161/CIRCINTERVENTIONS.114.002044.

    PubMed 25873729

  • Steg PG, Mehta S, Jolly S, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Chrolavicius S, Rao SV, Granger CB, Pogue J, Laing S, Yusuf S. Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.

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Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin and Open label fondaparinux in people with Acute Coronary Syndrome, run by GlaxoSmithKline at 203 sites in 18 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 8 inclusion and 22 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in Germany, Poland, India, Russia, Argentina and 13 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 7 Jun 2011). 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?

Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period (time frame: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)). 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 NCT00790907, which also lists 3 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 23 Mar 2017.

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