Clinical trial NCT00325390: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platelet Aggregation Inhibitors
NSTEACS
Keywords: SR25990C
Platelet Aggregation Inhibitors
NSTEACS
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Pharmaceuticals
First posted: 2006-05-12
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Incidence of effficacy and safety events
Secondary outcomes:
measure: Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events・
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Yuko HARADA
role: STUDY_DIRECTOR
References: