Acute Coronary DiseasePhase 3CURRENT/OASIS7NCT00335452

Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

A Phase 3 study testing Clopidogrel and acetylsalicyclic acid (ASA) in people with Acute Coronary Disease and Angina Unstable, run by Sanofi at 38 sites in 38 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 purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Disease, Angina Unstable
What is being tested?: Clopidogrel and acetylsalicyclic acid (ASA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25,086 participants
Where: 38 sitesin 38 countries
Study dates: Jun 2006to Sep 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated

Who cannot join

Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period
Administration of clopidogrel > 75 mg prior to randomization
Contraindication to clopidogrel or aspirin
Active bleeding or significant risk of bleeding

Trial locations and contacts

38 sites in 38 countries.

Country

City, postcode or hospital

38 sites in 38 countries

United States1 site

Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807

Other trials in United States

Argentina1 site

Sanofi-Aventis Administrative Office
Buenos Aires

Other trials in Argentina

Australia1 site

sanofi-aventis Australia & New Zealand administrative office
Macquarie Park

Other trials in Australia

Austria1 site

Sanofi-Aventis Administrative Office
Vienna

Other trials in Austria

Belgium1 site

Sanofi-Aventis Administrative Office
Diegem

Other trials in Belgium

Brazil1 site

Sanofi-Aventis Administrative Office
São Paulo

Other trials in Brazil

Bulgaria1 site

Sanofi-Aventis Administrative Office
Sofia

Other trials in Bulgaria

Canada1 site

Sanofi-Aventis Administrative Office
Laval

Other trials in Canada

Chile1 site

Sanofi-Aventis Administrative Office
Santiago

Other trials in Chile

China1 site

Sanofi-Aventis Administrative Office
Beijing

Other trials in China

Croatia1 site

Sanofi-Aventis Administrative Office
Zagreb

Other trials in Croatia

Czechia1 site

Sanofi-Aventis Administrative Office
Prague

Other trials in Czechia

Estonia1 site

Sanofi-Aventis Administrative Office
Tallinn

Other trials in Estonia

Finland1 site

Sanofi-Aventis Administrative Office
Helsinki

Other trials in Finland

France1 site

Sanofi-Aventis Administrative Office
Paris

Other trials in France

Germany1 site

Sanofi-Aventis Administrative Office
Berlin

Other trials in Germany

Greece1 site

Sanofi-Aventis Administrative Office
Athens

Other trials in Greece

India1 site

Sanofi-Aventis Administrative Office
Mumbai

Other trials in India

Ireland1 site

Sanofi-Aventis Administrative Office
Dublin

Other trials in Ireland

Israel1 site

Sanofi-Aventis Administrative Office
Netanya

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Italy1 site

Sanofi-Aventis Administrative Office
Milan

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Latvia1 site

Sanofi-Aventis Administrative Office
Riga

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Lithuania1 site

Sanofi-Aventis Administrative Office
Vilnius

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Malaysia1 site

Sanofi-Aventis Administrative Office
Kuala Lumpur

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Mexico1 site

Sanofi-Aventis Administrative Office
México

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Netherlands1 site

Sanofi-Aventis Administrative Office
Gouda

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Poland1 site

Sanofi-Aventis Administrative Office
Warsaw

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Romania1 site

Sanofi-Aventis Administrative Office
Bucharest

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Russia1 site

Sanofi-Aventis Administrative Office
Moscow

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Singapore1 site

Sanofi-Aventis Administrative Office
Singapore

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Slovakia1 site

Sanofi-Aventis Administrative Office
Brastislava

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South Africa1 site

Sanofi-Aventis Administrative Office
Midrand

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South Korea1 site

Sanofi-Aventis Administrative Office
Seoul

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Spain1 site

Sanofi-Aventis Admnistrative Office
Madrid

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Sweden1 site

Sanofi-Aventis Administrative Office
Bromma

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Switzerland1 site

Sanofi-Aventis Administrative Office
Geneva

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Turkey (Türkiye)1 site

Sanofi-Aventis Administrative Office
Istanbul

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United Kingdom1 site

Sanofi-Aventis Administrative Office
Guildford, Surrey

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About this study

Official title: Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.

Conditions: Acute Coronary Disease, Angina Unstable
Being tested: Clopidogrel, acetylsalicyclic acid (ASA)
Keywords: platelet aggregation inhibitors, acute coronary disease, percutaneous coronary
Medical subject headings: Angina, Unstable

What participants receive

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

ClopidogrelDrug
Also called SR25990, Plavix
oral administration
acetylsalicyclic acid (ASA)Drug
oral administration

Study groups in NCT00335452
Study group	Role	What they receive
Clopidogrel high dose treatment regimen + ASA high dose	Experimental	Not described Receives: Drug: Clopidogrel; Drug: acetylsalicyclic acid (ASA)
Clopidogrel high dose treatment regimen + ASA low dose	Experimental	Not described Receives: Drug: Clopidogrel; Drug: acetylsalicyclic acid (ASA)
Clopidogrel standard treatment regimen + ASA high dose	Active comparator	Not described Receives: Drug: Clopidogrel; Drug: acetylsalicyclic acid (ASA)
Clopidogrel standard treatment regimen + ASA low dose	Active comparator	Not described Receives: Drug: Clopidogrel; Drug: acetylsalicyclic acid (ASA)

What is being measured

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

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
The primary endpoint is the first occurrence of any of the following events:
- Cardiovascular death (any death with a clear cardiovascular or unknown cause),
- Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)
- Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
Measured: 30 days
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
Measured: 30 days
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
Measured: 30 days
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
Measured: 30 days

Secondary outcomes (2)

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.
Measured: 30 days
Occurrence of Major Bleeding - ASA Dose Level Comparison
Measured: 30 days

Timeline

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

Jun 2006Sep 2009

First posted9 Jun 2006 (estimated)
Study startJun 2006
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Acute Coronary DiseaseStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 25,086 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00335452
Sponsor's protocol ID: EFC5965
Other IDs: EUDRACT: 2006-000313-38
Acronym: CURRENT/OASIS7
Status last verified: Nov 2010
First submitted: 8 Jun 2006
Last updated: 18 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

CURRENT-OASIS 7 Investigators; Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475.
PubMed 20818903
Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. doi: 10.1056/NEJMe1008891. No abstract available.
PubMed 20818910
Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.
PubMed 20817281
Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Oct 9;376(9748):1203-5. doi: 10.1016/S0140-6736(10)61262-7. No abstract available.
PubMed 20817280
Eikelboom JW, Mehta SR, Yi Q, Weitz JI. Aspirin dose, urinary thromboxane and prostacyclin metabolites, and clinical outcome in acute coronary syndrome: A nested case-control study from CURRENT-OASIS 7. Thromb Res. 2026 Jul 21;264:109788. doi: 10.1016/j.thromres.2026.109788. Online ahead of print.
PubMed 42508308
Bossard M, Gao P, Boden W, Steg G, Tanguay JF, Joyner C, Granger CB, Kastrati A, Faxon D, Budaj A, Pais P, Di Pasquale G, Valentin V, Flather M, Moccetti T, Yusuf S, Mehta SR. Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease. Heart. 2021 Nov;107(21):1739-1747. doi: 10.1136/heartjnl-2020-318045. Epub 2021 Jan 27.
PubMed 33504513
Bossard M, Granger CB, Tanguay JF, Montalescot G, Faxon DP, Jolly SS, Widimsky P, Niemela K, Steg PG, Natarajan MK, Gao P, Fox KAA, Yusuf S, Mehta SR. Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Nov 3;6(11):e006577. doi: 10.1161/JAHA.117.006577.
PubMed 29101117
Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. Am Heart J. 2008 Dec;156(6):1080-1088.e1. doi: 10.1016/j.ahj.2008.07.026. Epub 2008 Nov 1.
PubMed 19033002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.
ClinicalTrials.gov ID: NCT00335452
Acronym / sponsor ID: CURRENT/OASIS7 / EFC5965
Conditions: Acute Coronary Disease, Angina Unstable
Keywords: platelet aggregation inhibitors, acute coronary disease, percutaneous coronary
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 25,086 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jun 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 9 Jun 2006 (estimated)
Results: Posted 7 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Clopidogrel high dose treatment regimen + ASA high dose	Experimental	Drug: Clopidogrel, Drug: acetylsalicyclic acid (ASA)
Clopidogrel high dose treatment regimen + ASA low dose	Experimental	Drug: Clopidogrel, Drug: acetylsalicyclic acid (ASA)
Clopidogrel standard treatment regimen + ASA high dose	Active comparator	Drug: Clopidogrel, Drug: acetylsalicyclic acid (ASA)
Clopidogrel standard treatment regimen + ASA low dose	Active comparator	Drug: Clopidogrel, Drug: acetylsalicyclic acid (ASA)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated

Key exclusion criteria (4 listed)

Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period
Administration of clopidogrel > 75 mg prior to randomization
Contraindication to clopidogrel or aspirin
Active bleeding or significant risk of bleeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClopidogrelAlso: SR25990, Plavixoral administration	Drug	Clopidogrel high dose treatment regimen + ASA high dose, Clopidogrel high dose treatment regimen + ASA low dose, Clopidogrel standard treatment regimen + ASA high dose, Clopidogrel standard treatment regimen + ASA low dose
acetylsalicyclic acid (ASA)oral administration	Drug	Clopidogrel high dose treatment regimen + ASA high dose, Clopidogrel high dose treatment regimen + ASA low dose, Clopidogrel standard treatment regimen + ASA high dose, Clopidogrel standard treatment regimen + ASA low dose

Primary outcome

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
Time frame: 30 days
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
Time frame: 30 days
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
Time frame: 30 days
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
Time frame: 30 days

2 secondary outcomes

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
Time frame: 30 days
Occurrence of Major Bleeding - ASA Dose Level Comparison
Time frame: 30 days

Results and safety

Results posted to the registry on 7 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clopidogrel 300/75/75 mg + ASA Low Dose	6,312	6,154
Clopidogrel 300/75/75 mg + ASA High Dose	6,254	6,107
Clopidogrel 600/150/75 mg + ASA Low Dose	6,267	6,108
Clopidogrel 600/150/75 mg + ASA High Dose	6,253	6,122

Primary outcome: First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison

Time frame: 30 days. Number. Unit: participants

Measure	Clopidogrel 300/75/75 mg + ASA n = 12566	Clopidogrel 600/150/75 mg + ASA n = 12520
CV death/MI/Stroke	557	522
- CV death	222	226
- MI (fatal or not)	274	237
- Stroke (fatal or not)	61	59

Clopidogrel 300/75/75 mg + ASA vs Clopidogrel 600/150/75 mg + ASA: Relative Risk Reduction (%): 6.1 (95% CI -5.8 to 16.6), p = 0.3037, Log Rank

Population analysed: The analysis is on the intent-to-treat population (ITT) that consists of all patients randomized irrespective of whether they received study medication, underwent a PCI, or otherwise complied with the study protocol.

Primary outcome: First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison

Time frame: 30 days. Number. Unit: participants

Measure	Clopidogrel + ASA Low Dose n = 12563	Clopidogrel + ASA High Dose n = 12498
CV death/MI/Stroke	546	527
- CV death	231	211
- MI (fatal or not)	260	251
- Stroke (fatal or not)	55	65

Clopidogrel + ASA Low Dose vs Clopidogrel + ASA High Dose: Relative Risk Reduction (%): 3.1 (95% CI -9.2 to 14.0), p = 0.6047, Log Rank

Population analysed: The analysis is on the the ASA treated population that consists of all patients randomized and having receiving at least one dose of ASA. All patients were included in the treatment group to which they were allocated by the AReS.

Primary outcome: First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level

Time frame: 30 days. Number. Unit: participants

Measure	Clopidogrel 300/75/75 mg + ASA Low Dose n = 6312	Clopidogrel 300/75/75 mg + ASA High Dose n = 6254	Clopidogrel 600/150/75 mg + ASA Low Dose n = 6267	Clopidogrel 600/150/75 mg + ASA High Dose n = 6253
Value	267	290	282	240

Clopidogrel 300/75/75 mg + ASA Low Dose vs Clopidogrel 600/150/75 mg + ASA Low Dose: Relative Risk Reduction (%): -6.5 (95% CI -26.0 to 9.9), p = 0.4579, Log Rank
Clopidogrel 300/75/75 mg + ASA High Dose vs Clopidogrel 600/150/75 mg + ASA High Dose: Relative Risk Reduction (%): 17.6 (95% CI 2.2 to 30.5), p = 0.0262, Log Rank
Clopidogrel 300/75/75 mg + ASA Low Dose vs Clopidogrel 300/75/75 mg + ASA High Dose vs Clopidogrel 600/150/75 mg + ASA Low Dose vs Clopidogrel 600/150/75 mg + ASA High Dose: p = 0.0355, Chi-squared

Primary outcome: First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup

Time frame: 30 days. Number. Unit: participants

Measure	Clopidogrel 300/75/75 mg + ASA n = 8703	Clopidogrel 600/150/75 mg + ASA n = 8560
CV death/MI/Stroke	392	330
- CV death	132	130
- MI (fatal or not)	225	172
- Stroke (fatal or not)	35	28

Clopidogrel 300/75/75 mg + ASA vs Clopidogrel 600/150/75 mg + ASA: Relative Risk Reduction (%): 14.7 (95% CI 1.2 to 26.3), p = 0.0332, Log Rank

Population analysed: The intent-to-treat (ITT) analysis is done on the randomized patients who underwent PCI during the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clopidogrel 300/75/75 mg + ASA Low Dose	322 of 6,312 (5.1%)	0 of 6,312 (0%)	Not reported
Clopidogrel 300/75/75 mg + ASA High Dose	329 of 6,254 (5.3%)	0 of 6,254 (0%)	Not reported
Clopidogrel 600/150/75 mg + ASA Low Dose	372 of 6,267 (5.9%)	0 of 6,267 (0%)	Not reported
Clopidogrel 600/150/75 mg + ASA High Dose	332 of 6,253 (5.3%)	0 of 6,253 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20818903CURRENT-OASIS 7 Investigators; Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475.
Results publication: PubMed 20818910Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. doi: 10.1056/NEJMe1008891. No abstract available.
Results publication: PubMed 20817281Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.
Results publication: PubMed 20817280Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Oct 9;376(9748):1203-5. doi: 10.1016/S0140-6736(10)61262-7. No abstract available.
Derived from this study: PubMed 42508308Eikelboom JW, Mehta SR, Yi Q, Weitz JI. Aspirin dose, urinary thromboxane and prostacyclin metabolites, and clinical outcome in acute coronary syndrome: A nested case-control study from CURRENT-OASIS 7. Thromb Res. 2026 Jul 21;264:109788. doi: 10.1016/j.thromres.2026.109788. Online ahead of print.
Derived from this study: PubMed 33504513Bossard M, Gao P, Boden W, Steg G, Tanguay JF, Joyner C, Granger CB, Kastrati A, Faxon D, Budaj A, Pais P, Di Pasquale G, Valentin V, Flather M, Moccetti T, Yusuf S, Mehta SR. Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease. Heart. 2021 Nov;107(21):1739-1747. doi: 10.1136/heartjnl-2020-318045. Epub 2021 Jan 27.
Derived from this study: PubMed 29101117Bossard M, Granger CB, Tanguay JF, Montalescot G, Faxon DP, Jolly SS, Widimsky P, Niemela K, Steg PG, Natarajan MK, Gao P, Fox KAA, Yusuf S, Mehta SR. Double-Dose Versus Standard-Dose Clopidogrel According to Smoking Status Among Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Nov 3;6(11):e006577. doi: 10.1161/JAHA.117.006577.
Derived from this study: PubMed 19033002Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Fox KA, Granger CB, Jolly S, Rupprecht HJ, Widimsky P, Yusuf S; CURRENT-OASIS 7 Steering Committee. Design and rationale of CURRENT-OASIS 7: a randomized, 2 x 2 factorial trial evaluating optimal dosing strategies for clopidogrel and aspirin in patients with ST and non-ST-elevation acute coronary syndromes managed with an early invasive strategy. Am Heart J. 2008 Dec;156(6):1080-1088.e1. doi: 10.1016/j.ahj.2008.07.026. Epub 2008 Nov 1.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shamir MEHTA, MD principal investigator

Hamilton General Hospital, McMaster University, CANADA

38 sites in 38 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel and acetylsalicyclic acid (ASA) in people with Acute Coronary Disease and Angina Unstable, run by Sanofi at 38 sites in 38 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 1 inclusion and 4 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 18 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Argentina, Australia, Austria, Belgium and 33 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 7 Oct 2010). 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?

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison (time frame: 30 days). The study lists 4 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 NCT00335452, which also lists 8 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 18 Nov 2010.