NCT02777580

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 609 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Tenecteplase	Half dose Tenecteplase
DRUG	Clopidogrel	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
PROCEDURE	Primary PCI	Primary PCI accoring to local standards

Timeline

• Start date: 2017-08-01
• Primary completion: 2022-10-13
• Completion: 2023-09-30
• First posted: 2016-05-19
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

50 sites across 10 countries: Australia, Brazil, Canada, Chile, France, Mexico, Montenegro, Russia, Serbia, Spain