STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction (STREAM-2)
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|ClinicalTrials.gov Identifier: NCT02777580|
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Drug: Tenecteplase Drug: Clopidogrel Procedure: Coronary angiography Procedure: Primary PCI||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Pharmaco-invasive strategy
Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required.
Half dose Tenecteplase
300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
Procedure: Coronary angiography
Coronary angiography followed by PCI or CABG if required, rescue PCI if required
Active Comparator: Standard primary PCI
Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
Procedure: Primary PCI
Primary PCI accoring to local standards
- Number of patients achieving ≥ 50 % ST-segment resolution before and after PCI; needing rescue PCI; demonstrating TIMI flow grades (0,1,2,3); with aborted MI. [ Time Frame: 30 days ]
- Number of patients with stroke (total, intracranial haemorrhage, ischaemic, haemorrhagic conversion) and non-intracranial bleeds. Number of patients with serious cardiac events. [ Time Frame: 30 days ]Serious cardiac events (e.g. death , congestive heart failure, reinfarction, resuscitated ventricular fibrillation, repeat target vessel recanalization, stent thrombosis, total AV block etc).
- Composite endpoints (e.g. death, shock, heart failure and recurrent MI) will be assessed as described in the statistical analytical plan. [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777580
|Contact: Katleen Vandenberghe, PhDfirstname.lastname@example.org|
|Contact: Anne Luyten, MDemail@example.com|
|Study Chair:||Frans Van de Werf, MD, PhD||KU Leuven|
|Study Chair:||Paul Armstrong, MD||University of Alberta, Edmonton, Canada|
|Principal Investigator:||Peter Sinnaeve, MD, PhD||UZ Leuven, Belgium|
|Principal Investigator:||Robert Welsh, MD||University of Alberta, Edmonton, Canada|
|Principal Investigator:||Patrick Goldstein, MD||Lille University Hospital, France|