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OpenTrials
Completed

NCT Number: NCT00335452

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

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).

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Key information

Conditions

Acute Coronary Disease Angina Pectoris Angina Unstable Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

oral administration

Other names: SR25990, Plavix

acetylsalicyclic acid (ASA)

Drug

oral administration

Primary outcomes

  1. 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).

  2. First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison

    Time frame: 30 days

  3. First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level

    Time frame: 30 days

  4. First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup

    Time frame: 30 days

Secondary outcomes

  1. 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.

  2. Occurrence of Major Bleeding - ASA Dose Level Comparison

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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.

Acronym: CURRENT/OASIS7

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 9, 2006
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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