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

Sponsors and Collaborators:	Sanofi-Aventis 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, stroke, myocardial infarction) after a percutaneous coronary intervention.

Condition	Intervention	Phase
Acute Coronary Disease Angina Unstable	Drug: clopidogrel (SR25990) Drug: acetylsalicyclic acid (ASA)	Phase III

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Factorial Assignment, Efficacy 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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

First occurrence of cardiovascular death, myocardial infarction and stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25000
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clopidogrel: high loading dose, ASA: high dose	Drug: clopidogrel (SR25990) oral administration Drug: acetylsalicyclic acid (ASA) oral administration
2: Experimental Clopidogrel: high loading dose, ASA: low dose	Drug: clopidogrel (SR25990) oral administration Drug: acetylsalicyclic acid (ASA) oral administration
3: Active Comparator Clopidogrel: standard dose, ASA: high dose	Drug: clopidogrel (SR25990) oral administration Drug: acetylsalicyclic acid (ASA) oral administration
4: Active Comparator Clopidogrel: standard dose, ASA: low dose	Drug: clopidogrel (SR25990) oral administration 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

Contacts

Contact: Public Registry ICD

GV-Contact-us@sanofi-aventis.com

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

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC5965, SR 25990C
Study First Received:	June 8, 2006
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00335452
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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Arteriosclerosis
Ischemia
Recurrence

Chest Pain
Coronary Disease
Signs and Symptoms
Aspirin
Clopidogrel
Infarction
Myocardial Infarction
Angina, Unstable
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009