Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS - Full Text View

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00335452

Purpose

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	Intervention	Phase
Acute Coronary Disease Angina Unstable	Drug: Clopidogrel Drug: acetylsalicyclic acid (ASA)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

Drug Information available for: Aspirin Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level [ Time Frame: 30 days ] [ Designated as safety issue: No ]
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	25086
Study Start Date:	June 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335452

Show 38 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Principal Investigator:

Shamir MEHTA, MD

Hamilton General Hospital, McMaster University, CANADA

More Information

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.

Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):976-7. 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; on behalf of the 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 Sep 1; [Epub ahead of print]

Stone GW. Acute coronary syndromes: finding meaning in OASIS 7. Lancet. 2010 Sep 1; [Epub ahead of print] No abstract available.

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

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. Epub 2008 Nov 1.

Responsible Party:	ICD, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00335452 History of Changes
Other Study ID Numbers:	EFC5965, EUDRACT: 2006-000313-38
Study First Received:	June 8, 2006
Results First Received:	September 15, 2010
Last Updated:	November 9, 2010
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Sanofi-Aventis:

platelet aggregation inhibitors
acute coronary disease
percutaneous coronary

Additional relevant MeSH terms:

Angina Pectoris
Angina, Unstable
Coronary Disease
Coronary Artery Disease
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin

Ticlopidine
Clopidogrel
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on May 22, 2012