POPular-TAVI
Research type
Research Study
Full title
Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation
IRAS ID
199319
Contact name
Colum Owens
Contact email
Sponsor organisation
St. Antonius Hospital
Eudract number
2013-003125-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 27 days
Research summary
Transcatheter aortic valve implantation (TAVI) has become an established treatment for patients with severe symptomatic aortic stenosis. Despite improving experience and techniques, bleeding and ischemic complications such as stroke after TAVI remain prevalent and impair survival. Current guidelines recommend the temporary addition of the bloodthinner clopidogrel in the initial period after TAVI to prevent ischemic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in ischemic complications. \nThe POPular TAVI trial is a randomized open-label clinical trial to test if monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: in cohort A, patients are randomized to aspirin versus aspirin + clopidogrel (3 months); in cohort B, patients on OAC therapy are randomized to OAC versus OAC + clopidogrel (3 months). The study began in February 2014 and will continue until a total of 1.000 patients are included (684 expected in cohort A and 316 in cohort B) and followed for 1 year. This is a European study, in which at least two hospitals in the United Kingdom are expected to participate.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0790
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion