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Taking peoplePhase 2/3

Shorter versus longer aspirin after a heart valve replacement for aortic stenosis

Compares 90 days with 12 months of aspirin after transcatheter aortic valve replacement.

Key facts

Who runs it
Centre Hospitalier Universitaire De Caen Normandie
Where
France19 sites in 1 countryChoose a country to see its sites
Registry title
Short versus long antiplatelet therapy after TAVI
Status
Recruiting
Phase
Phase 2/3
People taking part
1,400 people, planned
Started
21 Nov 2024
Expected to end
15 Jan 2027
Type of study
Interventional
Record updated
17 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a successful TAVI (a new aortic valve put in through the groin artery) for aortic stenosis with symptoms. It compares 90 days with 12 months of aspirin 75 to 100 mg.

Age
18 years or older.
Sex
Men, and women who cannot become pregnant: no periods for 12 months without another medical cause, or permanently sterilized (hysterectomy, removal of both tubes or both ovaries).
Disease stage
Symptomatic aortic stenosis (narrowed aortic valve) treated with a successful transfemoral TAVI. Success means the device was placed correctly, as a single valve, with no surgery or procedure needed for device or major access complications (a permanent pacemaker is allowed).
Earlier treatment
People cannot join if they took long-term antiplatelet or blood-thinning medicine before TAVI for another reason.

Main reasons for not taking part

  • TAVI not through the groin, valve-in-valve TAVI, or TAVI for pure aortic regurgitation (leaky valve).
  • Any reason to need long-term antiplatelet medicine, such as coronary artery disease, stroke-related disease or peripheral artery disease.
  • Any reason to need blood thinners by mouth, such as atrial fibrillation, deep vein thrombosis or pulmonary embolism.
  • Cannot take long-term aspirin: allergy or intolerance, major bleeding, high bleeding risk, platelets < 50 000, major clotting disorder.
  • Women who could become pregnant; adults under legal guardianship. Participants must speak French and have French social security.

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Age ≥ 18
  • Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
  • Written informed consent
  • Social security affiliated
  • French speaking
  • 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

Who cannot take part

  • Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
  • Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
  • Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
  • Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia < 50 000, major haemostasis disorder…)
  • Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI
  • Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
  • 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
  • Adult with protective measures (tutorship, curatorship)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Non-inferiority of the experimental arm (90 days therapy with 75 to 100 mg oral aspirin) compared to standard arm (12 months therapy with 75 to 100 mg oral aspirin) on a composite clinical event at 12 months follow-up

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Short versus long antiplatelet therapy after TAVI
Plain-language title
Shorter versus longer aspirin after a heart valve replacement for aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
17 April 2026