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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: enoxaparin; Procedure: primary PCI; Procedure: catheterisation; Drug: tenecteplase; Drug: clopidogrel

• Registration Number: NCT00623623
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Study Start: 2008-03-01
• Primary Completion: 2012-09-01
• Study Completion: 2012-09-01
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Disposition First Posted: 2014-05-16
• Status Verified: 2019-06
• Results First Submitted: 2019-06-06
• Results First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-08-01
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1899

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenecteplase	catheterisation	Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Tenecteplase	enoxaparin	Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
Tenecteplase	clopidogrel	Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention
primary PCI	primary PCI	Standard primary PCI
Tenecteplase	tenecteplase	Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention

Primary Outcome Measures

Name	Time	Method
Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.	30 days	The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS).

Secondary Outcome Measures

Name	Time	Method
Number of Patients With All Cause Mortality	30 days	This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported.
Number of Patients With Cardiogenic Shock	30 days	This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported.
Number of Patients With Recurrent Myocardial Infarction (Reinfarction)	30 days	This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported
Number of Patients With Rehospitalisation for Cardiac Reasons	30 days	This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported
Number of Patients With Rehospitalisation for Non-cardiac Reasons	30 days	This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported
Number of Patients With Cardiac Mortality	30 days	This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported.
Number of Patients With Congestive Heart Failure (CHF)	30 days	This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported.
Number of Patients With Serious Repeat Target Vessel Revascularization	30 days	This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported
Number of Patients With All Cause Death and Shock	30 days	This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported
Number of Patients With All Cause Death and Shock and CHF	30 days	This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported.
Number of Patients With All Cause Death and Shock and Reinfarction	30 days	This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported
Number of Patients With Total Fatal Stroke	30 days	This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported
Number of Patients With Total Disabling Stroke	30 days	This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported
Number of Patients With Total Non-disabling Stroke	30 days	This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported
Number of Patients With Intracranial Haemorrhage	30 days	This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported
Number of Patients With Ischaemic Stroke	30 days	This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported
Number of Patients With Total Stroke (All Types)	30 days	This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported
Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions	30 days	This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported
Number of Patients With Minor Non-intracranial Bleeds	30 days	This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported
Number of Patients With Total Non-intracranial Bleeds	30 days	This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported
Number of Patients With Serious Resuscitated Ventricular Fibrillation	30 days	This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported
Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures	30 days	This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported
Number of Patients With All Cause Death and Non-fatal Stroke	30 days	This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported
Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke	30 days	This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported

Trial Locations

Locations (200)

1123.28.43009 Boehringer Ingelheim Investigational Site; 🇦🇹 Salzburg, Austria

1123.28.43010 Boehringer Ingelheim Investigational Site; 🇦🇹 Salzburg, Austria

1123.28.43001 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43002 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43003 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43004 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43005 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43007 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.43008 Boehringer Ingelheim Investigational Site; 🇦🇹 Wien, Austria

1123.28.32060 Boehringer Ingelheim Investigational Site; 🇧🇪 Bornem, Belgium

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