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

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00623623

Purpose

This study aims at evaluating, in a proof of concept approach, the outcome of pre-hospital patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset. Following randomisation a strategy of early (pre-hospital) 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	Drug: Tenecteplase Drug: Clopidogrel, Enoxaparin Procedure: Catheterisation	Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Enoxaparin Sodium Clopidogrel Clopidogrel Bisulfate Antithrombin III Tenecteplase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Pre-Hospital 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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Single efficacy endpoints within 30 days: All cause mortality Cardiogenic shock Congestive heart failure (CHF) Recurrent MI (reinfarction) Rehospitalisation for cardiac reasons Rehospitalisation for non cardiac reasons [ Time Frame: 30 days ]

Secondary Outcome Measures:

Single safety endpoints within 30 days: Ischaemic stroke Intracranial haemorrhage Non intracranial bleeds Serious clinical events [ Time Frame: 30 days / discharge or day 4 (whichever occurs earlier) ]

Estimated Enrollment:	2000
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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
12-lead ECG indicative of an acute STEMI
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

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 200 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1123.28, EudraCT 2007-0061219-44
Study First Received:	February 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00623623
Health Authority:	Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicines and Health Products; Brazil: Agência Nacional de Vigilância Sanitária - ANVISA; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175; Great Britain: Medicines and Healthcare products Regulatory Agency (MHRA); Italy: Comitato Etico dell'A.O. San Gerardo - MONZA (MI); Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Spain: Agencia Espanola del Medicamento y Productos Sanitarios Campezo 1. 28022 Madrid

Study placed in the following topic categories:

Necrosis
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Tenecteplase

Ischemia
Infarction
Antithrombin III
Myocardial Infarction
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009