Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Platelet Aggregation Inhibitors; NSTEACS
Intervention: SR25990C (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Yuko HARADA, Study Director, Affiliation: Sanofi-Aventis
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).
Clinical Details
Official title: Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of effficacy and safety events
Secondary outcome: Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sanofi-Aventis, Tokyo, Japan
Additional Information
Starting date: July 2004
Last updated: May 11, 2006
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