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-NL

Enrollment

2200

Registered

2013-11-07

Start date

2013-12-24

Completion date

Unknown

Last updated

2020-05-04

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. Heart team agrees on indication and treatment proposal; 2. Patient has provided written informed consent; Cohort B 1. Heart team agrees on indication and treatment proposal; 2. Need for long-term oral anticoagulation; 3. Patient has provided written informed consent. Cohort C 1. Heart team agrees on indication and treatment proposal; 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 2200

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 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. Allergy or intolerance to clopidogrel. Cohort C 1. Patient is younger than 65 years old; 2. Combination surgical procedure.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients without an indication for oral anticoagulation (OAC) after TAVI (Cohort A); 2. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients with an indication for OAC after TAVI (Cohort B); ;Secondary Objective: 1. To investigate the safety and efficacy of the studied antithrombotic treatment regimens after TAVI compared with the common practiced antithrombotic treatment after surgical aortic valve replacement (SAVR) (Cohort C); 2. Furthermore we obtain to investigate the effect of omission of clopidogrel on cognitive and functional parameters, quality of life and costs.;Primary end point(s): Primary safety outcome is defined as all bleeding. Co-primary safety outcome is defined as all non-procedure related bleeding. ;Timepoint(s) of evaluation of this end point: 30 days and 12 months	—

Measure

Time frame

Main Objective: 1. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients without an indication for oral anticoagulation (OAC) after TAVI (Cohort A); 2. To investigate the safety and efficacy of omission of clopidogrel during follow-up in patients with an indication for OAC after TAVI (Cohort B); ;Secondary Objective: 1. To investigate the safety and efficacy of the studied antithrombotic treatment regimens after TAVI compared with the common practiced antithrombotic treatment after surgical aortic valve replacement (SAVR) (Cohort C); 2. Furthermore we obtain to investigate the effect of omission of clopidogrel on cognitive and functional parameters, quality of life and costs.;Primary end point(s): Primary safety outcome is defined as all bleeding. Co-primary safety outcome is defined as all non-procedure related bleeding. ;Timepoint(s) of evaluation of this end point: 30 days and 12 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy outcome is a composite of cardiovascular mortality, major bleeding, life threatening/disabling bleeding, all-cause stroke, and myocardial infarction. Co-secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, all-cause stroke, and myocardial infarction.;Timepoint(s) of evaluation of this end point: 30 days and 12 months	—

Measure

Time frame

Secondary end point(s): Secondary efficacy outcome is a composite of cardiovascular mortality, major bleeding, life threatening/disabling bleeding, all-cause stroke, and myocardial infarction. Co-secondary efficacy outcome is a composite of cardiovascular mortality, non-procedure related bleeding, all-cause stroke, and myocardial infarction.;Timepoint(s) of evaluation of this end point: 30 days and 12 months

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Countries

Belgium, Netherlands, 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