Conditions: Myocardial Infarction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1899
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention arm 2: Standard primary PCI

Interventions: intervention 1: primary PCI intervention 2: enoxaparin intervention 3: catheterisation intervention 4: tenecteplase intervention 5: clopidogrel
Intervention descriptions: intervention 1: Standard primary PCI intervention 2: Adjunctive treatment intervention 3: Routine or rescue coronary intervention intervention 4: Single, weight-adjusted i.v. bolus of tenecteplase intervention 5: Adjunctive treatment

Protocol document: