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

Primary Purpose

Platelet Aggregation Inhibitors, NSTEACS

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
clopidogrel (SR25990C)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Platelet Aggregation Inhibitors focused on measuring SR25990C, Platelet Aggregation Inhibitors, NSTEACS

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Incidence of effficacy and safety events

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2006
Last Updated
March 24, 2009
Sponsor
Sanofi
Collaborators
Daiichi Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00325390
Brief Title
Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Daiichi Pharmaceuticals

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Aggregation Inhibitors, NSTEACS
Keywords
SR25990C, Platelet Aggregation Inhibitors, NSTEACS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
clopidogrel (SR25990C)
Primary Outcome Measure Information:
Title
Incidence of effficacy and safety events
Secondary Outcome Measure Information:
Title
Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuko HARADA
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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