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

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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Clopidogrel bisulfate Tenecteplase

U.S. FDA Resources

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 (Adult, Senior)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bainey KR, Fresco C, Zheng Y, Halvorsen S, Carvalho A, Ostojic M, Goldstein P, Gershlick AH, Westerhout CM, Van de Werf F, Armstrong PW; STREAM Investigators. Implications of ischaemic area at risk and mode of reperfusion in ST-elevation myocardial infarction. Heart. 2016 Apr;102(7):527-33. doi: 10.1136/heartjnl-2015-308075. Epub 2016 Jan 18.

Shavadia J, Zheng Y, Dianati Maleki N, Huber K, Halvorsen S, Goldstein P, Gershlick AH, Wilcox R, Van de Werf F, Armstrong PW. Infarct Size, Shock, and Heart Failure: Does Reperfusion Strategy Matter in Early Presenting Patients With ST-Segment Elevation Myocardial Infarction? J Am Heart Assoc. 2015 Aug 24;4(8):e002049. doi: 10.1161/JAHA.115.002049.

Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.

Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.

Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

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. doi: 10.1016/j.ahj.2010.04.007.


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 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

ClinicalTrials.gov processed this record on September 26, 2016