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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
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1899 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
Actual Study Start Date : March 1, 2008
Actual Primary Completion Date : September 1, 2012
Actual Study Completion Date : September 1, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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. Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. [ Time Frame: 30 days ]
    The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).


Secondary Outcome Measures :
  1. Number of Patients With All Cause Mortality [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.

  2. Number of Patients With Cardiac Mortality [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.

  3. Number of Patients With Cardiogenic Shock [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.

  4. Number of Patients With Congestive Heart Failure (CHF) [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported.

  5. Number of Patients With Recurrent Myocardial Infarction (Reinfarction) [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported

  6. Number of Patients With Rehospitalisation for Cardiac Reasons [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported

  7. Number of Patients With Rehospitalisation for Non-cardiac Reasons [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported

  8. Number of Patients With Serious Repeat Target Vessel Revascularization [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported

  9. Number of Patients With All Cause Death and Shock [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported

  10. Number of Patients With All Cause Death and Shock and CHF [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported.

  11. Number of Patients With All Cause Death and Shock and Reinfarction [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported

  12. Number of Patients With Total Fatal Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported

  13. Number of Patients With Total Disabling Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported

  14. Number of Patients With Total Non-disabling Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported

  15. Number of Patients With Intracranial Haemorrhage [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported

  16. Number of Patients With Ischaemic Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported

  17. Number of Patients With Total Stroke (All Types) [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported

  18. Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported

  19. Number of Patients With Minor Non-intracranial Bleeds [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported

  20. Number of Patients With Total Non-intracranial Bleeds [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported

  21. Number of Patients With Serious Resuscitated Ventricular Fibrillation [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported

  22. Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported

  23. Number of Patients With All Cause Death and Non-fatal Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported

  24. Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke [ Time Frame: 30 days ]
    This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00623623    
Other Study ID Numbers: 1123.28
2007-001219-44 ( EudraCT Number: EudraCT )
First Posted: February 26, 2008    Key Record Dates
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Enoxaparin
Tenecteplase
Clopidogrel
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
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents