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
  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:

Primary Outcome Measures:
  • Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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:

  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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623623

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

No publications provided by Boehringer Ingelheim

Additional 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
Study First Received: February 15, 2008
Last Updated: April 30, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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
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
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014