Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Daiichi Pharmaceuticals
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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