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

NCT ID: NCT00335452

Last Updated: 2010-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25086 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Coronary Disease Angina Unstable

Keywords

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platelet aggregation inhibitors acute coronary disease percutaneous coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clopidogrel high dose treatment regimen + ASA high dose

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

oral administration

acetylsalicyclic acid (ASA)

Intervention Type DRUG

oral administration

Clopidogrel high dose treatment regimen + ASA low dose

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

oral administration

acetylsalicyclic acid (ASA)

Intervention Type DRUG

oral administration

Clopidogrel standard treatment regimen + ASA high dose

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

oral administration

acetylsalicyclic acid (ASA)

Intervention Type DRUG

oral administration

Clopidogrel standard treatment regimen + ASA low dose

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

oral administration

acetylsalicyclic acid (ASA)

Intervention Type DRUG

oral administration

Interventions

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Clopidogrel

oral administration

Intervention Type DRUG

acetylsalicyclic acid (ASA)

oral administration

Intervention Type DRUG

Other Intervention Names

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SR25990 Plavix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Shamir MEHTA, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton General Hospital, McMaster University, CANADA

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, , Australia

Site Status

Sanofi-Aventis Administrative Office

Vienna, , Austria

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Site Status

Sanofi-Aventis Administrative Office

Sofia, , Bulgaria

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Santiago, , Chile

Site Status

Sanofi-Aventis Administrative Office

Beijing, , China

Site Status

Sanofi-Aventis Administrative Office

Zagreb, , Croatia

Site Status

Sanofi-Aventis Administrative Office

Prague, , Czechia

Site Status

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Site Status

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Athens, , Greece

Site Status

Sanofi-Aventis Administrative Office

Mumbai, , India

Site Status

Sanofi-Aventis Administrative Office

Dublin, , Ireland

Site Status

Sanofi-Aventis Administrative Office

Netanya, , Israel

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Riga, , Latvia

Site Status

Sanofi-Aventis Administrative Office

Vilnius, , Lithuania

Site Status

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Site Status

Sanofi-Aventis Administrative Office

México, , Mexico

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Site Status

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Site Status

Sanofi-Aventis Administrative Office

Moscow, , Russia

Site Status

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Site Status

Sanofi-Aventis Administrative Office

Brastislava, , Slovakia

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Site Status

Sanofi-Aventis Admnistrative Office

Madrid, , Spain

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Site Status

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Sanofi-Aventis Administrative Office

Guildford, Surrey, United Kingdom

Site Status

Countries

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Denmark Hungary Norway Philippines United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Croatia Czechia Estonia Finland France Germany Greece India Ireland Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Poland Romania Russia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

References

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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.

Reference Type RESULT
PMID: 20818903 (View on PubMed)

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.

Reference Type RESULT
PMID: 20818910 (View on PubMed)

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.

Reference Type RESULT
PMID: 20817281 (View on PubMed)

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.

Reference Type RESULT
PMID: 20817280 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33504513 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29101117 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19033002 (View on PubMed)

Other Identifiers

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EUDRACT: 2006-000313-38

Identifier Type: -

Identifier Source: secondary_id

EFC5965

Identifier Type: -

Identifier Source: org_study_id