Short Versus Long Antiplatelet Therapy After TAVI

ConditionTranscatheter Aortic Valve Replacement

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Caen

About this trial

The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen).

The main questions it aims to answer are:

Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events.

Researchers will compare a short treatment by aspirin (3 months) to a long treatment by aspirin (12 months) after percutaneous replacement of the aortic valve.

Participants will:

Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3, 4, 6, 8, 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18

Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female

Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33

Successful access, delivery of the device, and retrieval of the delivery system

Disqualifiers

Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3

Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches

TAVI for other indications than aortic stenosis (pure aortic regurgitation)

Valve in valve TAVI

Trial design

Design model

Parallel

Treatments tested in this trial

Aspirin
Drug
Short duration of aspirin (3 months) is compared to long duration of aspirin (12 months)

Treatment groups

1,400 Participants

are divided into 2 treatment groups

Group A: Short treatmentExperimental treatment 1 intervention

Group B: long treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

Net clinical benefit

The composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system injury and non-procedure-related major or disabling bleeding VARC 3 types 2 or 3

Time frame

12 months after randomisation

Secondary outcomes

Non-procedure-related bleeding

VARC 3 classification 1 to 4 bleeding

Time frame

12 months

Major or disabling or life threatening bleeding

VARC 3 classification 2 or 3 bleeding

Time frame

12 months

Major cardiovascular events

The composite of all cause death, type 1 myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury

Time frame

12 months

Other outcomes

Minor bleeding

Type 1 VARC 3 classification bleeding

Time frame

12 months

Major bleeding

Type 2 VARC 3 classification bleeding

Time frame

12 months

Disabling or life threatening bleeding

Type 3 VARC 3 classification bleeding

Time frame

12 months

Fatal bleeding

Type 4 VARC 3 classification bleeding

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Caen

Lead sponsor

Source ClinicalTrials.gov

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