MedTrace Logo

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

NCT00623623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1899

Last updated 2019-08-01

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

PROCEDURE

primary PCI

Standard primary PCI

DRUG

enoxaparin

Adjunctive treatment

PROCEDURE

catheterisation

Routine or rescue coronary intervention

DRUG

tenecteplase

Single, weight-adjusted i.v. bolus of tenecteplase

DRUG

clopidogrel

Adjunctive treatment

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-01
Primary Completion
2012-09-01
Completion
2012-09-01

Countries

  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Greece
  • Italy
  • Norway
  • Peru
  • Poland
  • Russia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00623623 on ClinicalTrials.gov