Status:
COMPLETED
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Daiichi Pharmaceuticals
Conditions:
Platelet Aggregation Inhibitors
NSTEACS
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome ...
Eligibility Criteria
Inclusion
- Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:
- (1)Clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration).
- (2)Patients who meet either of following criteria
- ECG changes compatible with new ischemia \[e.g. ST depression (at least 1 mm), T wave inversion (at least 2 mm), or hyperacute peaked T waves in 2 contiguous leads\].
- already elevated CK at least twice the upper limit of normal or CK-MB or Troponin I or T above the upper limit of normal or positive qualitative test for Troponin T.
- (3)A percutaneous coronary intervention is planned within 96 hours after the first study drug administration
Exclusion
- A)Factors that affect participation in study:
- (1)Previous disabling stroke
- (2)Previous intracranial hemorrhage or hemorrhagic stroke
- (3)Severe co-morbid condition such that the patient is not expected to survive 1 month
- (4)NYHA Class IV heart failure
- (5)Uncontrolled hypertension
- (6)Requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or NSAIDs (excluding unum sumatur), during study period,
- B)Factors related to ASA and/or ticlopidine treatment:
- (1)Use of ticlopidine within 1 week prior to randomization
- (2)History of ASA or ticlopidine intolerance or allergy
- (3)Contraindications to ASA or ticlopidine
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00325390
Start Date
July 1 2004
Last Update
March 25 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan