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

Platelet Aggregation Inhibitors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325390
• Other study ID #: EFC6720
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2006
• Last updated: March 24, 2009
• Start date: July 2004

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• NSTEACS
• Platelet Aggregation Inhibitors

Intervention

Drug:
• clopidogrel (SR25990C)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Daiichi Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of effficacy and safety events
Secondary	Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events·