Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation

Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation - POPular-TAVI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003125-28-BE

Enrollment

1000

Registered

2017-03-27

Start date

2017-05-11

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis for which a transcatheter aortic valve implantation (TAVI) is performed.

Interventions

Trade Name: Plavix Pharmaceutical Form: Tablet INN or Proposed INN: clopidogrel CAS Number: 113665-84-2 Current Sponsor code: clopidogrel Other descriptive name: CLOPIDOGREL Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cohort A 1. Patient has provided written informed consent. Cohort B 1. Need for long-term oral anticoagulation; 2. Patient has provided written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000

Exclusion criteria

Exclusion criteria: Cohort A 1. Need for long-term oral anticoagulation. 2. Drug-eluting stent implantation within 3 months prior to TAVI procedure. 3. Bare-metal stent implantation within 1 month prior to TAVI procedure. 4. Allergy or intolerance or contraindication to aspirin or clopidogrel. Cohort B 1. Drug-eluting stent implantation within 3 months prior to TAVI procedure. 2. Bare-metal stent implantation within 1 month prior to TAVI procedure. 3. Use of non-vitamin K oral anticoagulation (NOAC). 4. Allergy or intolerance or contraindication to OAC or clopidogrel.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.To investigate the safety of omission of clopidogrel compared to a strategy using aspirin + clopidogrel during 1 year follow-up in patients without an indication for OAC after TAVI (Cohort A); 2.To investigate the safety of omission of clopidogrel compared to a strategy using OAC + clopidogrel during 1 year follow-up in patients with an indication for OAC after TAVI (Cohort B). ;Secondary Objective: 1.To investigate the net-clinical benefit of omission of clopidogrel compared to a strategy using aspirin + clopidogrel during 1 year follow-up in patients without an indication for OAC after TAVI (Cohort A); 2.To investigate the net-clinical benefit of omission of clopidogrel compared to a strategy using OAC + clopidogrel during 1 year follow-up in patients with an indication for OAC after TAVI (Cohort B); 3.To investigate the efficacy of omission of clopidogrel during 1 year follow-up in patients with and without an indication for OAC after TAVI (Cohort A + B); 4.To investigate the effects of genetic variations of CYP2C19 and PTGS2 on clinical outcomes. ;Primary end point(s): Primary safety outcome is defined non-procedure related bleeding an all bleeding.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: 1.To investigate the safety of omission of clopidogrel compared to a strategy using aspirin + clopidogrel during 1 year follow-up in patients without an indication for OAC after TAVI (Cohort A); 2.To investigate the safety of omission of clopidogrel compared to a strategy using OAC + clopidogrel during 1 year follow-up in patients with an indication for OAC after TAVI (Cohort B). ;Secondary Objective: 1.To investigate the net-clinical benefit of omission of clopidogrel compared to a strategy using aspirin + clopidogrel during 1 year follow-up in patients without an indication for OAC after TAVI (Cohort A); 2.To investigate the net-clinical benefit of omission of clopidogrel compared to a strategy using OAC + clopidogrel during 1 year follow-up in patients with an indication for OAC after TAVI (Cohort B); 3.To investigate the efficacy of omission of clopidogrel during 1 year follow-up in patients with and without an indication for OAC after TAVI (Cohort A + B); 4.To investigate the effects of genetic variations of CYP2C19 and PTGS2 on clinical outcomes. ;Primary end point(s): Primary safety outcome is defined non-procedure related bleeding an all bleeding.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 12 months;Secondary end point(s): Secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, stroke, and myocardial infarction. Secondary net-clinical benefit outcome is a composite of cardiovascular mortality, ischaemic stroke, and myocardial infarction.	—

Countries

Austria, Belgium, France, Netherlands, Switzerland, United Kingdom

Contacts

Public ContactVincent J. Nijenhuis

St. Antonius Hospital

v.nijenhuis@antoniusziekenhuis.nl00310306098055

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026