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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Pharmaceuticals
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00325390
First received: May 11, 2006
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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
Platelet Aggregation Inhibitors
NSTEACS
Drug: clopidogrel (SR25990C)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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・

Estimated Enrollment: 800
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325390

Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Daiichi Pharmaceuticals
Investigators
Study Director: Yuko HARADA Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325390     History of Changes
Other Study ID Numbers: EFC6720
Study First Received: May 11, 2006
Last Updated: March 24, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
SR25990C
Platelet Aggregation Inhibitors
NSTEACS

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014