Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

Stroke Clinical Trial

— POPular-TAVI  

Official title:

Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247128
• Other study ID #: POPTAV006
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At present, a variety of antithrombotic regimens are prescribed in the early postprocedure period after transcatheter aortic valve implantation (TAVI). Dual antiplatelet therapy (DAPT) using aspirin and a thienopyridine in the initial period after TAVI is the recommended strategy; however, mono antiplatelet therapy using aspirin is suggested not to be inferior. In patients with atrial fibrillation (AF) or another indication for oral anticoagulation (OAC), no recommendations on best treatment regimen currently exist although triple therapy (OAC + DAPT) is best avoided due to increased bleeding risk.

We hypothesise that the omission of clopidogrel in the first 3 months after TAVI is safer and not less beneficial than the addition of clopidogrel to aspirin (cohort A) or OAC (cohort B).

Description:

The trial consists of two cohorts:

• Cohort A, patients without an indication for OAC prior to TAVI.

• Cohort B, patients with an indication for OAC prior to TAVI (eg. atrial fibrillation, mechanic mitral valve prosthesis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1016
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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 (N)OAC or clopidogrel.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Bleeding
• Hemorrhage
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Drug:
• Aspirin + clopidogrel

• Aspirin monotherapy

• OAC + clopicogrel

• OAC monotherapy

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis	Aalst
Belgium	Onze Lieve Vrouwe Ziekenhuis	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Algemeen Ziekenhuis Sint Jan	Brugge
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Universitair Ziekenhuis Leuven	Leuven
Czechia	Charles university, Third Faculty of Medicine	Prague
Luxembourg	National Institute Surgery Cardiaque Et De Cardiologie Interventionnelle	Luxembourg
Netherlands	Academic Medical Centre (AMC)	Amsterdam	Noord Holland
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center	Groningen
Netherlands	Universitair Medisch Centrum Leiden	Leiden
Netherlands	Academic Hospital	Maastricht
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht
Netherlands	University Medical Center Utrecht (UMCU)	Utrecht
Netherlands	Isala Clinics	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Countries where clinical trial is conducted

Belgium,  Czechia,  Luxembourg,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pharmacoeconomics endpoint	Outcome measure is quality-adjusted life years	1 year
Primary	Safety endpoint	The primary outcome is a safety endpoint, defined as freedom of all bleeding complications at 1 year after TAVI. The co-primary outcome is the safety endpoint defined as freedom of non-procedure related bleeding complications at 1 year after TAVI. For the classification of bleeding complications the Bleeding Academic Research Consortium Definition for Bleeding (BARC) bleeding classification is primarily used according to the Valve Academic Research Consortium (VARC).	1 year
Secondary	Net-clinical benefit endpoint	The secondary outcome is a net-clinical benefit endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, non-procedure related bleeding, stroke, or myocardial infarction at 1 year after TAVI.	1 year
Secondary	Efficacy endpoint	The co-secondary outcome is an efficacy endpoint, defined as freedom of the non-hierarchical composite of cardiovascular mortality, ischemic stroke, or myocardial infarction at 1 year after TAVI.	1 year