STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00623623
First received: February 15, 2008
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Procedure: primary PCI Drug: enoxaparin Procedure: catheterisation Drug: tenecteplase Drug: clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- 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 MI (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: Yes ]
- Intracranial haemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Non intracranial bleeds [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Serious clinical events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- ECG and enzyme changes [ Time Frame: at or before discharge ] [ Designated as safety issue: No ]
- Total stroke (fatal, disabling, non-disabling) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Death and shock [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Death and shock and CHF [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Death and shock and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Death and shock and CHF and reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Death and non-fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 1891 |
| Study Start Date: | March 2008 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623623
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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00623623 History of Changes |
| Other Study ID Numbers: | 1123.28, 2007-001219-44 |
| Study First Received: | February 15, 2008 |
| Last Updated: | March 6, 2013 |
| Health Authority: | Austria: Medicines and Medical Devices Agency Belgium: Federal Agency for Medicines and Health Products Brazil: Agência Nacional de Vigilância Sanitária - ANVISA Canada: Health Canada Chile: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 Great Britain: Medicines and Healthcare products Regulatory Agency (MHRA) Greece: Ethics Committee Italy: Ethics Committee Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Peru: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Serbia and Montenegro: Agency for Drugs and Medicinal Devices Spain: Agencia Espanola del Medicamento y Productos Sanitarios Campezo 1. 28022 Madrid |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Clopidogrel Enoxaparin Tenecteplase Tissue Plasminogen Activator Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions 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 Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013