Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?

This is an interventional treatment trial for Acute Coronary Syndrome Read More

Inclusion Criteria:

• Must not be of child-bearing potential (1 year post-menopausal, contraceptive use or surgically sterile);
• Subject with a non-ST-segment elevation ACS defined by the presence of at least 2 of the following criteria: symptoms of myocardial ischemia, electrocardiographic ST-segment abnormalities (depression or transient elevation of at least 0.1 mV) or T-wave inversion in at least in 2 contiguous leads, or an elevated cardiac troponin value (above the upper limit of normal) ;
• Subject requiring intervention according to physician's judgment including the following criteria subject with one of the following risk factor defining intermediate and high risk ACS: diabetes mellitus, kidney failure, reduced LVEF, early post infarction angina, recent PCI, prior CABG or a GRACE risk score >109, recurrent symptoms or ischaemia on non-invasive testing (2);
• Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital;

Exclusion Criteria:

• - Minors or pregnant or breast-feeding women;
• Subject with low risk ACS;
• Subject with very high-risk ACS: refractory angina, severe heart failure, life-threatening ventricular arrhythmias, hemodynamic instability requiring immediate intervention;
• Subject with thrombolytic therapy during the preceding 24 hours;
• Subject with bleeding diathesis;
• Subject with Upstream treatment by a GPIIb/IIIa inhibitor;
• Subject under chronic anticoagulant;
• Subject participating in another research protocol;
• Subject not agreeing to participate;
• Subject with contraindication to or under chronic P2Y12 receptor antagonists therapy (clopidogrel, ticagrelor and prasugrel);
• Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization into the study defined as follows:

• ST-segment elevation myocardial infarction is defined as a history of chest discomfort or ischemic symptoms of >20 minutes duration at rest ≤14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:

  1. ST-segment elevation ≥1 mm in two or more contiguous ECG leads.
  2. New or presumably new left bundle branch block (LBBB).
  3. ST-segment depression ≥1 mm in two anterior precordial leads (V1 through V4) with clinical history and evidence suggestive of true posterior infarction.
• Have cardiogenic shock (systolic blood pressure <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion);
• Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF).