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Completed

NCT Number: NCT00325390

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

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).

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Key information

Conditions

Platelet Aggregation Inhibitors NSTEACS

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel (SR25990C)

Drug

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・

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Daiichi Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2004
First posted
May 12, 2006
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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