Antiplatelet therapy for patients undergoing transcatheter aortic valve implantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25546

Enrollment

1000

Registered

2014-11-19

Start date

2014-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Aortic valve disease

Interventions

Cohort A Random 1:1 allocation to aspirin alone (at least until 1 year) (intervention) versus clopidogrel (3 months) + aspirin (at least until 1 year) (control), 1 day before TAVI in patients without

Cohort B Random 1:1 allocation to OAC alone (intervention) versus OAC + clopidogrel (3 months) (control), 1 day before TAVI in patients with an indication for OAC at baseline.

Eligibility

Inclusion criteria

Inclusion criteria: Cohort A 1. Patient has provided written informed consent. Cohort B 2. Need for long-term oral anticoagulation; 3. Patient has provided written informed consent.

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. Use of non-vitamin K oral anticoagulation (NOAC); 4. Allergy or intolerance to OAC or clopidogrel.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Contacts

Public ContactJ.M. ten Berg

Koekoekslaan 1, 3435CM Nieuwegein

j.ten.berg@antoniusziekenhuis.nl+31 88 320 1121

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)