STUDY POPULATION

Inclusion Criteria

Patients admitted to hospital with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1mm, and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia were eligible for the study if they gave informed consent and met the following criteria:

  • clinical history 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).

and:

  • either ECG changes compatible with new ischemia (eg. ST depression (at least 1 mm in 2 contiguous leads), T wave inversion (at least 2 mm in 2 contiguous leads), or hyperacute peaked T waves).
  • or already elevated cardiac enzymes or Troponin I or T to at least twice the upper limit of normal, provided there is no ST segment elevation.

Patients presented with new LBBB were included if they were not eligible for thrombolysis and met the other inclusion criteria.



Exclusion Criteria

Factors that affect participation in study:

  1. Age < 21 years
  2. Previous disabling stroke (severe cerebral deficit such that the patient is bedridden or demented)
  3. Previous intracranial hemorrhage or hemorrhagic stroke
  4. Severe co-morbid condition such that the patient is not expected to survive 12 months
  5. NYHA Class IV heart failure
  6. Uncontrolled hypertension
  7. Current use of oral anticoagulants, non study antiplatelet agents (including ticlopidine or clopidogrel) or NSAIDs with the intension for long term (>3 months) and regular treatment
  8. Patients concurrently participating in any study with an investigational drug or device
  9. Patients having received a glycoprotein IIB/IIIA receptor antagonist in the previous three days
  10. Patients with previous participation in this study
  11. Patients with recent PTCA/Stent or CABG (within 3 months prior to randomization)
  12. Women of child-bearing potential who are not following an effective method of contraception
  13. Geographic or social factors making study participation impractical
  14. Coronary angiography in the year prior to the eligibility assessment, showing no evidence of significant coronary disease or intraluminal slot

Factors related to ASA and/or clopidogrel treatment:

  1. Clinically severe thrombocytopenia or neutropenia
  2. History of ASA intolerance
  3. Contraindications to clopidogrel or ASA, including patients at high risk of bleeding


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