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Sponsors and Collaborators: |
Sanofi-Aventis Daiichi Pharmaceuticals |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00325390 |
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).
Condition | Intervention | Phase |
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Platelet Aggregation Inhibitors NSTEACS |
Drug: SR25990C |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
(2)Patients who meet either of following criteria
Exclusion Criteria:
A)Factors that affect participation in study:
B)Factors related to ASA and/or ticlopidine treatment:
Study ID Numbers: | EFC6720, SR25990C |
Study First Received: | May 11, 2006 |
Last Updated: | May 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00325390 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency |
SR25990C Platelet Aggregation Inhibitors NSTEACS |
Ticlopidine Heart Diseases Myocardial Ischemia |
Acute Coronary Syndrome Vascular Diseases Ischemia |
Cardiovascular Diseases |