Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS (CURRENT/OASIS7)

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ClinicalTrials.gov Identifier: NCT00335452

Recruitment Status : Completed

First Posted : June 9, 2006

Results First Posted : October 7, 2010

Last Update Posted : November 18, 2010

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by:

Sanofi

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Acute Coronary Disease Angina Unstable	Drug: Clopidogrel Drug: acetylsalicyclic acid (ASA)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25086 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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.
Study Start Date :	June 2006
Actual Primary Completion Date :	September 2009
Actual Study Completion Date :	September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel Clopidogrel bisulfate

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Clopidogrel high dose treatment regimen + ASA high dose	Drug: Clopidogrel oral administration Other Names: SR25990 Plavix Drug: acetylsalicyclic acid (ASA) oral administration
Experimental: Clopidogrel high dose treatment regimen + ASA low dose	Drug: Clopidogrel oral administration Other Names: SR25990 Plavix Drug: acetylsalicyclic acid (ASA) oral administration
Active Comparator: Clopidogrel standard treatment regimen + ASA high dose	Drug: Clopidogrel oral administration Other Names: SR25990 Plavix Drug: acetylsalicyclic acid (ASA) oral administration
Active Comparator: Clopidogrel standard treatment regimen + ASA low dose	Drug: Clopidogrel oral administration Other Names: SR25990 Plavix Drug: acetylsalicyclic acid (ASA) oral administration

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison [ Time Frame: 30 days ]
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.
Occurrence of Major Bleeding - ASA Dose Level Comparison [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335452

Locations

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, Australia
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago de Chile, Chile
China
Sanofi-Aventis Administrative Office
Beijing, China
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
India
Sanofi-Aventis Administrative Office
Mumbai, India
Ireland
Sanofi-Aventis Administrative Office
Dublin, Ireland
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Latvia
Sanofi-Aventis Administrative Office
Riga, Latvia
Lithuania
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
Slovakia
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Admnistrative Office
Madrid, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom

Sponsors and Collaborators

Sanofi

Bristol-Myers Squibb

Investigators

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Principal Investigator:	Shamir MEHTA, MD	Hamilton General Hospital, McMaster University, CANADA

More Information

Publications of Results:

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. Erratum In: N Engl J Med. 2010 Oct 14;363(16):1585.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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Responsible Party:	ICD, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00335452
Other Study ID Numbers:	EFC5965 EUDRACT: 2006-000313-38
First Posted:	June 9, 2006 Key Record Dates
Results First Posted:	October 7, 2010
Last Update Posted:	November 18, 2010
Last Verified:	November 2010

Keywords provided by Sanofi:


platelet aggregation inhibitors acute coronary disease percutaneous coronary

Additional relevant MeSH terms:

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Coronary Disease Coronary Artery Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Clopidogrel	Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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