MedPath

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)

Not Applicable
Conditions
-I21
I21
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
Inclusion Criteria

• 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.

Exclusion Criteria

• 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath