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

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00623623

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	Drug: tenecteplase Drug: enoxaparin Drug: clopidogrel Procedure: catheterisation Procedure: primary PCI	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:

MedlinePlus related topics: Heart Attack Shock

Drug Information available for: Clopidogrel Bisulfate Tenecteplase Enoxaparin Sodium

U.S. FDA Resources

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 ]

Estimated Enrollment:	2000
Study Start Date:	March 2008
Estimated Primary Completion Date:	August 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: tenecteplase Single, weight-adjusted i.v. bolus of tenecteplase Drug: enoxaparin Adjunctive treatment Drug: clopidogrel Adjunctive treatment Procedure: catheterisation Routine or rescue coronary intervention
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

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Show 193 Study Locations

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):

Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1.

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:	May 2, 2012
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) Greece: Ethics Committee India: Drugs Controller General of India 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 17, 2012