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

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ClinicalTrials.gov Identifier: NCT00623623
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: primary PCI Drug: enoxaparin Procedure: catheterisation Drug: tenecteplase Drug: clopidogrel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]
  2. Cardiogenic shock [ Time Frame: 30 days ]
  3. Congestive heart failure (CHF) [ Time Frame: 30 days ]
  4. Recurrent myocardial infarction (reinfarction) [ Time Frame: 30 days ]
  5. Rehospitalisation for cardiac reasons [ Time Frame: 30 days ]
  6. Rehospitalisation for non-cardiac reasons [ Time Frame: 30 days ]
  7. Ischaemic stroke [ Time Frame: 30 days ]
  8. Intracranial haemorrhage [ Time Frame: 30 days ]
  9. Major non-intracranial bleeds including blood transfusions [ Time Frame: 30 days ]
  10. Minor non-intracranial bleeds [ Time Frame: 30 days ]
  11. Total non-intracranial bleeds [ Time Frame: 30 days ]
  12. Total disabling stroke [ Time Frame: 30 days ]
  13. Total fatal stroke [ Time Frame: 30 days ]
  14. Total non-disabling stroke [ Time Frame: 30 days ]
  15. Total stroke (all types) [ Time Frame: 30 days ]
  16. All cause death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ]
  17. Cardiac mortality [ Time Frame: 30 days ]
  18. All cause death and shock [ Time Frame: 30 days ]
  19. All cause death and shock and reinfarction [ Time Frame: 30 days ]
  20. All cause death and shock and CHF [ Time Frame: 30 days ]
  21. All cause death and non-fatal stroke [ Time Frame: 30 days ]
  22. Serious repeat target vessel revascularization [ Time Frame: 30 days ]
  23. Serious resuscitated ventricular fibrillation [ Time Frame: 30 days ]
  24. Serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) [ Time Frame: 30 days ]


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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623623


  Show 201 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00623623     History of Changes
Other Study ID Numbers: 1123.28
2007-001219-44 ( EudraCT Number: EudraCT )
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Tenecteplase
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