Patients with non-ST segment elevation myocardial infarction managed with an early PCI. MedDRA version: 8.1 Level: LLT Classification code 10064347
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Clopidogrel
CAS Number: 120202-66-6
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ACS patients 1.1 UA/NSTEMI patients: Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction [NSTEMI]) defined as: Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exertion (lasting longer than 10 minutes) and planned to be managed with an early invasive strategy with intent to perform a percutaneous coronary intervention (PCI) as early as possible and no later than 72 hours of randomization. AND at least one of the following a) Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1 mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 3 mm in at least 2 contiguous leads]. or b) Already elevated cardiac enzymes (e.g. CKMB) or biomarkers (troponin I or T) above the upper limit of normal. OR 1.2 STEMI patients: a) Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an early invasive strategy, i.e. with an intent to perform a percutaneaous coronary intervention (PCI) as early as possible and no later than 72 hours of randomization (this may include either primary PCI or initial management with medical therapy). b) Definite ECG changes compatible with STEMI persistent ST-elevation (=2mm in two contiguous precordial leads, or > 1mm in at least two limb leads) new left bundle branch block or Q wave in 2 contiguous leads. 2. Randomized within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia/infarction. 3. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age 1.5 or planned use during the hospitalization period 3. Administration of clopidogrel > 75 mg within 24 hours prior to randomization 4. Contraindication to the use of clopidogrel and/or ASA: • History of drug allergy to thienopyridine derivatives or ASA • History of clinically significant or persistent thrombocytopenia or neutropenia 5. Active bleeding or significant increased risk of bleeding, such as elderly patients receiving fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding (e.g. gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, or intracranial hemorrhage), or other history of bleeding diathesis or coagulopathy 6. Uncontrolled hypertension 7. Previously entered in the study 8. Investigational treatment (drug or device) within the previous 30 days 9. Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent and to understand the full meaning of the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a high dose regimen of clopidogrel (600 mg loading dose [LD] followed by 150 mg once daily (o.d) from Day 2 to 7, then 75 mg o.d) is superior to a standard dose of clopidogrel (300 mg LD followed by 75 mg o.d) in preventing the composite of cardiovascular death, MI or stroke in acute coronary syndromes (ACS) patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI), or ST segment myocardial infarction (STEMI), who are treated with an early invasive strategy with an intent to perform a PCI as early as possible and no later than 72 hours of randomization. Also to determine, in a factorial design, whether a high dose of acetylsalicylic acid (ASA) is superior to a low dose ASA in preventing the composite of cardiovascular death, MI or stroke.;Secondary Objective: To evaluate the safety of the clopidogrel high dose regimen compared to the standard dose regimen in terms of major bleeding (i.e. severe bleeding and other major bleeding). To evaluate the safety of the ASA high dose regimen (300-325 mg) compared to the low dose (75-100 mg) regimen in terms of major bleeding (i.e. severe bleeding and other major bleeding) and the net efficacy to safety balance of death or MI or stroke to major bleeding.;Primary end point(s): PRIMARY ENDPOINTS FOR CLOPIDOGREL DOSE COMPARISONS: First efficacy endpoint: First occurrence of any component of the composite cluster of cardiovascular (CV) death, MI or stroke at 30 Days. Primary safety endpoint: Major bleeding (i.e. severe bleeding and other major bleeding) at 30 Days. PRIMARY ENDPOINTS FOR ASA DOSE COMPARISONS: Primary efficacy endpoint: First occurrence of any component of the composite cluster of cardiovascular (CV) death, MI or stroke at 30 Days. Safety endpoint: Major bleeding (i.e. severe bleeding and other major bleeding) at 30 days. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed