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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Myocardial Infarction	Procedure: primary PCI; Drug: enoxaparin; Procedure: catheterisation; Drug: tenecteplase; Drug: clopidogrel	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1891 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	March 2008
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Primary: all cause death and shock and CHF and reinfarction at day 30 [ Time Frame: 30 days ]

Secondary Outcome Measures :

1. All cause mortality [ Time Frame: 30 days ]
2. Cardiogenic shock [ Time Frame: 30 days ]
3. Congestive heart failure (CHF) [ Time Frame: 30 days ]
4. Recurrent myocardial infarction (reinfarction) [ Time Frame: 30 days ]
5. Rehospitalisation for cardiac reasons [ Time Frame: 30 days ]
6. Rehospitalisation for non-cardiac reasons [ Time Frame: 30 days ]
7. Ischaemic stroke [ Time Frame: 30 days ]
8. Intracranial haemorrhage [ Time Frame: 30 days ]
9. Major non-intracranial bleeds including blood transfusions [ Time Frame: 30 days ]
10. Minor non-intracranial bleeds [ Time Frame: 30 days ]
11. Total non-intracranial bleeds [ Time Frame: 30 days ]
12. Total disabling stroke [ Time Frame: 30 days ]
13. Total fatal stroke [ Time Frame: 30 days ]
14. Total non-disabling stroke [ Time Frame: 30 days ]
15. Total stroke (all types) [ Time Frame: 30 days ]
16. All cause death and shock and CHF and reinfarction and disabling stroke [ Time Frame: 30 days ]
17. Cardiac mortality [ Time Frame: 30 days ]
18. All cause death and shock [ Time Frame: 30 days ]
19. All cause death and shock and reinfarction [ Time Frame: 30 days ]
20. All cause death and shock and CHF [ Time Frame: 30 days ]
21. All cause death and non-fatal stroke [ Time Frame: 30 days ]
22. Serious repeat target vessel revascularization [ Time Frame: 30 days ]
23. Serious resuscitated ventricular fibrillation [ Time Frame: 30 days ]
24. Serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) [ Time Frame: 30 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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  Show 201 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

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

Shavadia J, Welsh R, Gershlick A, Zheng Y, Huber K, Halvorsen S, Steg PG, Van de Werf F, Armstrong PW. Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study. J Am Heart Assoc. 2016 Jun 13;5(6). pii: e003559. doi: 10.1161/JAHA.116.003559.

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.

Gershlick AH, Westerhout CM, Armstrong PW, Huber K, Halvorsen S, Steg PG, Ostojic M, Goldstein P, Carvalho AC, Van de Werf F, Wilcox RG. Impact of a pharmacoinvasive strategy when delays to primary PCI are prolonged. Heart. 2015 May;101(9):692-8. doi: 10.1136/heartjnl-2014-306686. Epub 2015 Feb 17.

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 ( EudraCT Number: EudraCT )
First Posted:	February 26, 2008
Last Update Posted:	May 16, 2014
Last Verified:	April 2014

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