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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00623623
First received: February 15, 2008
Last updated: April 30, 2014
Last verified: April 2014

February 15, 2008
April 30, 2014
March 2008
September 2012   (final data collection date for primary outcome measure)
Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks). [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00623623 on ClinicalTrials.gov Archive Site
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiogenic shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Congestive heart failure (CHF) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Recurrent myocardial infarction (reinfarction) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Rehospitalisation for non-cardiac reasons [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Ischaemic stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Intracranial haemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major non-intracranial bleeds including blood transfusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Minor non-intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Total non-intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Total disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total non-disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total stroke (all types) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and shock and CHF [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • All cause death and non-fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serious repeat target vessel revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Serious resuscitated ventricular fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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) ]
Not Provided
Not Provided
 
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • Procedure: primary PCI
    Standard primary PCI
  • 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
  • Experimental: Tenecteplase
    Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
    Interventions:
    • Drug: enoxaparin
    • Procedure: catheterisation
    • Drug: tenecteplase
    • Drug: clopidogrel
  • primary PCI
    Standard primary PCI
    Intervention: Procedure: primary PCI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1891
September 2012
September 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Chile,   Peru,   Greece,   Belgium,   France,   Spain,   Serbia,   Italy,   Austria,   United Kingdom,   Norway,   Poland,   Germany,   Brazil,   Russian Federation
 
NCT00623623
1123.28, 2007-001219-44
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP