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

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ClinicalTrials.gov Identifier: NCT00325390
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : March 25, 2009
Sponsor:
Collaborator:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 800 participants
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 : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions


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

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325390


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

ClinicalTrials.gov Identifier: NCT00325390     History of Changes
Other Study ID Numbers: EFC6720
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
SR25990C
Platelet Aggregation Inhibitors
NSTEACS

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs