Tracking Information
| Start Date ICMJE | March 2008 |
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| Estimated Primary Completion Date | December 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 History | Complete list of historical versions of study NCT00623623 on ClinicalTrials.gov 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 ICMJE | STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction |
|---|---|
| Official Title ICMJE | STREAM (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 Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE | Myocardial Infarction |
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
Recruitment Information
| Estimated Enrollment ICMJE | 2000 | ||||
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| Completion Date | |||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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 | ||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria, Belgium, Brazil, Canada, France, Germany, Italy, Norway, Poland, Russian Federation, Spain, United Kingdom |
Administrative Information
| NCT ID ICMJE | NCT00623623 | ||||
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| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study ID Numbers ICMJE | 1123.28, EudraCT 2007-0061219-44 | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals |