STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

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

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

Sponsors & Collaborators

• Boehringer Ingelheim

  collaborator INDUSTRY

• Life Sciences Research Partners

  collaborator OTHER

• Frans Van de Werf Fund for Clinical Cardiovascular Research

  collaborator OTHER

• KU Leuven

  lead OTHER

Principal Investigators

• Frans Van de Werf, MD, PhD · KU Leuven

• Paul Armstrong, MD · University of Alberta, Edmonton, Canada

• Peter Sinnaeve, MD, PhD · UZ Leuven, Belgium

• Robert Welsh, MD · University of Alberta, Edmonton, Canada

• Patrick Goldstein, MD · Lille University Hospital, France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2022-10-13

Completion

2023-09-30

Countries

• Australia
• Brazil
• Canada
• Chile
• France
• Mexico
• Montenegro
• Russia
• Serbia
• Spain

Study Locations