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Completed

NCT Number: NCT00623623

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

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1123.28.43009 Boehringer Ingelheim Investigational Site, Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age equal or greater than 18 years
  • 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

Treatment and study plan

Primary PCI

Procedure

Standard primary PCI

Enoxaparin

Drug

Adjunctive treatment

catheterisation

Procedure

Routine or rescue coronary intervention

Tenecteplase

Drug

Single, weight-adjusted i.v. bolus of tenecteplase

clopidogrel

Drug

Adjunctive treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 26, 2008
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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