STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Procedure: primary PCI; Procedure: catheterisation; Drug: clopidogrel; Drug: enoxaparin; Drug: tenecteplase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623623

1123.28

2007-001219-44 (EudraCT Number)

Details and patient eligibility

About

This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

Enrollment: 1,899 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age equal or greater than 18 years
2. Onset of symptoms < 3 hours prior to randomisation 3.12-lead ECG indicative of an acute STEMI

4.Informed consent received

Exclusion criteria

Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,899 participants in 2 patient groups

Tenecteplase

Experimental group

Description:

Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention

Treatment:

Drug: tenecteplase

Drug: enoxaparin

Procedure: catheterisation

Drug: clopidogrel

primary PCI

Other group

Description:

Standard primary PCI

Treatment:

Procedure: primary PCI