Phase 3 N=1,899 Randomized Treatment

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

Myocardial Infarction

Bottom Line

View on ClinicalTrials.gov: NCT00623623 ↗

Enrolled (actual)

1,899

Serious AEs

16.3%

Results posted

Aug 2019

Primary outcome: Primary: Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS. — 116; 135 Participants — p=0.195

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: primary PCI (Procedure); enoxaparin (Drug); catheterisation (Procedure); tenecteplase (Drug); clopidogrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With All-cause Mortality, Cardiogenic Shock, Congestive Heart Failure and Recurrent Myocardial Infarction Within 30 Days for FAS.	116; 135	0.195
SECONDARY Number of Patients With All Cause Mortality	43; 42	0.904
SECONDARY Number of Patients With Cardiac Mortality	31; 32	0.905
SECONDARY Number of Patients With Cardiogenic Shock	41; 56	0.120
SECONDARY Number of Patients With Congestive Heart Failure (CHF)	57; 72	0.170
SECONDARY Number of Patients With Recurrent Myocardial Infarction (Reinfarction)	23; 21	0.758
SECONDARY Number of Patients With Rehospitalisation for Cardiac Reasons	45; 41	0.663
SECONDARY Number of Patients With Rehospitalisation for Non-cardiac Reasons	19; 11	0.148
SECONDARY Number of Patients With Serious Repeat Target Vessel Revascularization	1; 2	0.572
SECONDARY Number of Patients With All Cause Death and Shock	59; 73	0.207
SECONDARY Number of Patients With All Cause Death and Shock and CHF	100; 123	0.100
SECONDARY Number of Patients With All Cause Death and Shock and Reinfarction	77; 85	0.511
SECONDARY Number of Patients With Total Fatal Stroke	7; 4	0.369
SECONDARY Number of Patients With Total Disabling Stroke	2; 0	0.168
SECONDARY Number of Patients With Total Non-disabling Stroke	8; 1	0.049 sig
SECONDARY Number of Patients With Intracranial Haemorrhage	9; 2	0.054
SECONDARY Number of Patients With Ischaemic Stroke	6; 3	0.324
SECONDARY Number of Patients With Total Stroke (All Types)	15; 5	0.032 sig
SECONDARY Number of Patients With Major Non-intracranial Bleeds Including Blood Transfusions	61; 45	0.111
SECONDARY Number of Patients With Minor Non-intracranial Bleeds	206; 191	0.397
SECONDARY Number of Patients With Total Non-intracranial Bleeds	267; 236	0.107
SECONDARY Number of Patients With Serious Resuscitated Ventricular Fibrillation	32; 38	0.471
SECONDARY Number of Patients With Serious Resuscitated Ventricular Fibrillation in Association With Invasive Procedures	10; 29	0.003 sig
SECONDARY Number of Patients With All Cause Death and Non-fatal Stroke	50; 43	0.451
SECONDARY Number of Patients With All Cause Death and Shock and CHF and Reinfarction and Disabling Stroke	117; 135	0.220

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00623623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.