STUDY DEFINITIONS

CV Death: defined as

  • Any death with a clear cardiovascular (including hemorrhagic) or unknown cause

Note: only deaths due to a documented non-vascular cause will be classified as non-CV.

MI: defined as at least 2 of 3 criteria

  1. Ischemic Chest Pain (x20 min, + sl nitro or narcotic)
  2. Elevated cardiac enzymes to at least 2 x upper limit of normal
  3. ECG changes
    • ST elevation of at least 1 mm in 2 cont. leads, or
    • persistent ST segment depression, or
    • persistent T wave inversion, or
    • Q waves

MI Post-PTCA defined as: at least 2 of the 3 criteria listed above (enzymes must be evaluated to at least 3 x the upper limit of normal)

MI Post CABG defined as:

  1. elevation of cardio-specific enzymes to at least 5 x the upper limit of normal, or
  2. development of new pathological Q waves

Stroke: defined as

  • New focal neurological deficit
  • Vascular in origin
  • Signs and symptoms > 24 hours
  • CT scan / MRI strongly recommended

    To be further classified as:
    • Ischemic
    • Hemorrhagic
    • Uncertain type

Refractory Ischemia: defined as

Either: During Initial Hospitalization

  • recurrent chest pain >5 min
  • ischemic ECG changes
  • on optimal medical therapy
  • must lead to additional intervention/procedure by midnight of the next day

Or: Rehospitalization for Unstable Angina

  • > 24 hr hospital stay
  • prolonged chest pain unresponsive to usual Rx
  • and ischemic ECG changes

    (may or may not lead to intervention/procedure)

Severe Ischemia: defined as

During Initial Hospitalization

  • At least 1 episode of chest pain > 5 min
  • On optimal medical therapy
  • Documented ischemic ECG changes

Note:

  • Differs from Refractory Ischemia - no intervention by midnight of next day

Recurrent Angina: defined as

During Initial Hospitalization

  • At least 1 episode of chest pain > 5 min
  • Increase in or addition of new anti-anginal med (narcotic if on optimal medical therapy)

Documented ECG changes - not required

Coronary Revascularization: defined as

  • PTCA
  • PTCA/Stent
  • CABG
  • Thrombolytic Therapy

Note:

  • Urgent if performed within 1 week of (re)hospitalization for acute MI or UA

Bleeding Definitions:

Life-threatening: defined as fatal or leading to a drop in hemoglobin of at least 5 g/dl, or significant hypotension with the need for inotropes, or requiring surgery (other than vascular site repair), or symptomatic intracranial hemorrhage, or requiring transfusion of four or more units of red blood cells or equivalent whole blood

Major: defined as significantly disabling, intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of two or three units of red blood cells or equivalent whole blood

Minor: Any other bleeding requiring modification of the study drug regimen.



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