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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00325390
• Collaborator: Daiichi Pharmaceuticals (Industry)
• Enrollment: 800
• Location: 1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Platelet Aggregation Inhibitors; NSTEACS	Drug: clopidogrel (SR25990C)	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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 Start Date: Jul 1, 2004

Outcome Measures

Primary Outcome Measures

1. Incidence of effficacy and safety events []

Secondary Outcome Measures

1. Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・ []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• 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:

• (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Tokyo		Japan

Sponsors and Collaborators

• Sanofi
• Daiichi Pharmaceuticals

Investigators

• Study Director: Yuko HARADA, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00325390
• Other Study ID Numbers: EFC6720
• First Posted: May 12, 2006
• Last Update Posted: Mar 25, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: SR25990C; Platelet Aggregation Inhibitors; NSTEACS
• Additional relevant MeSH terms: Acute Coronary Syndrome; Clopidogrel

Study Results

No Results Posted as of Mar 25, 2009