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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623623
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

February 15, 2008
February 26, 2008
May 16, 2014
March 2008
September 2012   (Final data collection date for primary outcome measure)
Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ]
The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks). [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00623623 on Archive Site
  • 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 ]
Key secondary endpoint for regulatory purpose is the change from baseline in HbA1c after 52 wks of treatment Change from baseline in FPG after 52 and 104 weeks of treatment [ Time Frame: - 30 days; discharge or day 4 (whichever occurs earlier) ]
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STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
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

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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myocardial Infarction
  • 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
  • Experimental: Tenecteplase
    Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
    • Drug: enoxaparin
    • Procedure: catheterisation
    • Drug: tenecteplase
    • Drug: clopidogrel
  • primary PCI
    Standard primary PCI
    Intervention: Procedure: primary PCI

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2012
September 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Brazil,   Canada,   Chile,   France,   Germany,   Greece,   Italy,   Norway,   Peru,   Poland,   Russian Federation,   Serbia,   Spain,   United Kingdom
2007-001219-44 ( EudraCT Number: EudraCT )
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Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP