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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Platelet Aggregation Inhibitors NSTEACS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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clopidogrel (SR25990C)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No