STREAM (STRATEGIC REPERFUSION EARLY AFTER MYOCARDIAL INFARCTION). COMPARISON OF THE EFFICACY AND SAFETY OF A STRATEGY OF EARLY FIBRINOLYTIC TREATMENT WITH TENECTEPLASE AND ADDITIONAL ANTIPLATELET AND ANTITHROMBIN THERAPY FOLLOWED BY CATHETERISATION WITHIN 6-24 HOURS OR RESCUE CORONARY INTERVENTION VERSUS A STRATEGY OF STANDARD PRIMARY PCI IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION WITHIN 3 HOURS OF ONSET OF SYMPTOMS. STREAM (STRATEGIC REPERFUSION EARLY AFTER MYOCARDIAL INFARCTION)
- Conditions
- -I21I21
- Registration Number
- PER-074-10
- Lead Sponsor
- Boehringer Ingelheim,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 6
• 18 years of age or older
• Symptom onset <3 hours before randomization
• The 12-lead ECG indicates an acute myocardial infarction with ST segment elevation (lAMEST), (the ST segment elevation will be measured from point J; 1 mm scale by 0.1 mV): ST segment elevation> 2 mm between two contiguous precordial leads (V1-V6) or leads I and aVL for a total minimum combined ST elevation> 4 mm or an ST elevation> 2 mm at two contiguous lower leads (II, III, aVF) for an elevation of the combined minimum ST total> 4 mm
• Obtaining the signed and dated informed consent.
• Expected time to perform an ICP <60 min from diagnosis (ECG) or inability to reach the catheterization laboratory in 3 hours
• Prior coronary artery bypass graft (CABG)
• His left bundle branch block (BRI) or ventricular stimulation with pacemaker implantation
• Killip IV class cardiogenic shock patients
• acientes with a body mass <55 Kg (known or estimated)
• Uncontrolled hypertension, indicated by a single measure> 180/110 mmHg (systolic BP> 180 mmHg and / or diastolic BP> 110 mmHg) prior to randomization
• Hospitalization for cardiac causes in the previous 48 hours
• Recent administration of anticoagulant drugs intravenously or subcutaneously in the previous 12 hours, such as unfractionated heparin,
• Enoxaparin and / or bivalirudin; or current use of oral anticoagulants (for example warfarin or coumarin)
• Active bleeding or known coagulation disorders / diathesis
• Known renal failure. All usual exclusion criteria for tenecteplase, clopidogrel and enoxaparin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method