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

Tracking Information

Start Date  ICMJEMarch 2008
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Single efficacy endpoints within 30 days: All cause mortality Cardiogenic shock Congestive heart failure (CHF) Recurrent MI (reinfarction) Rehospitalisation for cardiac reasons Rehospitalisation for non cardiac reasons [ Time Frame: 30 days ]
Original Primary Outcome Measures ICMJE 
 (submitted: February 25, 2008)
The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks). [ Time Frame: 30 days ]
Change HistoryComplete list of historical versions of study NCT00623623 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: April 25, 2008)
Single safety endpoints within 30 days: Ischaemic stroke Intracranial haemorrhage Non intracranial bleeds Serious clinical events [ Time Frame: 30 days / discharge or day 4 (whichever occurs earlier) ]
Original Secondary Outcome Measures ICMJE 
 (submitted: February 25, 2008)
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) ]

Descriptive Information

Brief Title  ICMJESTREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
Official Title  ICMJESTREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Pre-hospital 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
Brief Summary

This study aims at evaluating, in a proof of concept approach, the outcome of pre-hospital patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset. Following randomisation a strategy of early (pre-hospital) 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMyocardial Infarction
Intervention  ICMJE
  • Drug: Tenecteplase
  • Drug: Clopidogrel, Enoxaparin
  • Procedure: Catheterisation
Study Arms / Comparison Groups 

Recruitment Information

Estimated Enrollment  ICMJE2000
Completion Date 
Estimated Primary Completion DateDecember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study
Location Countries  ICMJEAustria,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Norway,   Poland,   Russian Federation,   Spain,   United Kingdom

Administrative Information

Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1123.28, EudraCT 2007-0061219-44
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals