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

NCT00325390 | Completed Phase 3

• 1 other identifier: EFC6720
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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).

Conditions

Platelet Aggregation Inhibitors; NSTEACS

Keywords

SR25990C; Platelet Aggregation Inhibitors; NSTEACS

Outcome Measures

Primary Outcomes (1)

• Incidence of effficacy and safety events

Secondary Outcomes (1)

• Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・

Interventions

clopidogrel (SR25990C) DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead
• Daiichi Pharmaceuticals: collaborator

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yuko HARADA

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2006
• First Posted: May 12, 2006
• Study Start: July 1, 2004
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

JP (1)