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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: February 15, 2008
Last updated: April 30, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Myocardial Infarction
Procedure: primary PCI
Drug: enoxaparin
Procedure: catheterisation
Drug: tenecteplase
Drug: clopidogrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ]
  • Cardiogenic shock [ Time Frame: 30 days ]
  • Congestive heart failure (CHF) [ Time Frame: 30 days ]
  • Recurrent myocardial infarction (reinfarction) [ Time Frame: 30 days ]
  • Rehospitalisation for cardiac reasons [ Time Frame: 30 days ]
  • Rehospitalisation for non-cardiac reasons [ Time Frame: 30 days ]
  • Ischaemic stroke [ Time Frame: 30 days ]
  • Intracranial haemorrhage [ Time Frame: 30 days ]
  • Major non-intracranial bleeds including blood transfusions [ Time Frame: 30 days ]
  • Minor non-intracranial bleeds [ Time Frame: 30 days ]
  • Total non-intracranial bleeds [ Time Frame: 30 days ]
  • Total disabling stroke [ Time Frame: 30 days ]
  • Total fatal stroke [ Time Frame: 30 days ]
  • Total non-disabling stroke [ Time Frame: 30 days ]
  • Total stroke (all types) [ Time Frame: 30 days ]
  • All cause death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ]
  • Cardiac mortality [ Time Frame: 30 days ]
  • All cause death and shock [ Time Frame: 30 days ]
  • All cause death and shock and reinfarction [ Time Frame: 30 days ]
  • All cause death and shock and CHF [ Time Frame: 30 days ]
  • All cause death and non-fatal stroke [ Time Frame: 30 days ]
  • Serious repeat target vessel revascularization [ Time Frame: 30 days ]
  • Serious resuscitated ventricular fibrillation [ Time Frame: 30 days ]
  • Serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) [ Time Frame: 30 days ]

Enrollment: 1891
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenecteplase
Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
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
primary PCI
Standard primary PCI
Procedure: primary PCI
Standard primary PCI


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00623623

  Show 201 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim Identifier: NCT00623623     History of Changes
Other Study ID Numbers: 1123.28
2007-001219-44 ( EudraCT Number: EudraCT )
Study First Received: February 15, 2008
Last Updated: April 30, 2014

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tissue Plasminogen Activator
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on April 28, 2017