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

NL-OMON

Registry ID

NL-OMON45158

Enrollment

500

Registered

2013-11-05

Start date

2013-12-11

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Aortic valve disease

Interventions

1. 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 an i

2. 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 (Cohort B).

Eligibility

Age

18 Years to 99 Years

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.

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. Allergy or intolerance or contraindication to OAC or clopidogrel.

Design outcomes

Primary

Measure	Time frame
Primary safety outcome is defined as all and non-procedure related bleeding (primarily classified according to BARC(Mehran et al., 2011) and also TIMI(Mega et al., 2009; Sabatine et al., 2009) and GUSTO(The GUSTO Investigators, 1993)).	—

Secondary

Measure	Time frame
Secondary net-clinical benefit outcome is a composite of cardiovascular mortality, non-procedural bleeding, stroke, and myocardial infarction. Secondary efficacy outcome is a composite of cardiovascular mortality, ischemic stroke, and myocardial infarction. Furthermore, we will register the composites of the primary and secondary outcomes, all-cause mortality, rehospitalisation and time to rehospitalisation, vascular complication (VC), number of blood transfusions, cardiac tamponade, transient ischemic attack (TIA), acute kidney injury, myocardial infarction and damage, prosthetic valve thrombosis, transvalvular aortic gradients, effective aortic valve area, paravalvular regurgitation, NYHA functional classification, combined early safety according to the VARC-2 Consensus(Kappetein et al., 2012), cost-effectiveness, frailty, and quality of life.	—

Measure

Time frame

Secondary net-clinical benefit outcome is a composite of cardiovascular mortality, non-procedural bleeding, stroke, and myocardial infarction. Secondary efficacy outcome is a composite of cardiovascular mortality, ischemic stroke, and myocardial infarction. Furthermore, we will register the composites of the primary and secondary outcomes, all-cause mortality, rehospitalisation and time to rehospitalisation, vascular complication (VC), number of blood transfusions, cardiac tamponade, transient ischemic attack (TIA), acute kidney injury, myocardial infarction and damage, prosthetic valve thrombosis, transvalvular aortic gradients, effective aortic valve area, paravalvular regurgitation, NYHA functional classification, combined early safety according to the VARC-2 Consensus(Kappetein et al., 2012), cost-effectiveness, frailty, and quality of life.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)