Short versus long antiplatelet therapy after TAVI

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

21 Nov 2024 → ongoing

Decision date (initial)

2024-03-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS (PHRC National)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 5

1. Superiority of the experimental arm in reducing all bleeding events
2. Superiority of the experimental arm in reducing clinically significant, major or disabling bleeding
3. Non inferiority of the experimental arm on the composite of major cardiovascular events
4. Comparison of individual components of composite end points and other secondary outcomes between the two arms
5. Mortality at 2 years follow-up assessed virtually on the national mortality database

Conditions and MedDRA coding

All adult patients with successful transfemoral trans-aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapy

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. • Age ≥ 18
2. • 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
3. • Written informed consent
4. • Social security affiliated
5. • French speaking
6. • 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

Exclusion criteria 10

1. • Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI
2. • Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
3. • TAVI for other indications than aortic stenosis (pure aortic regurgitation)
4. • Valve in valve TAVI
5. • Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
6. • Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
7. • Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
8. • 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…)
9. • Adult with protective measures (tutorship, curatorship)
10. • 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-

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI

Secondary endpoints 18

1. • Any non-procedure-related bleeding defined by the VARC classification 1 to 4
2. • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3
3. • Major cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury
4. • Type 1 VARC classification bleeding
5. • Type 2 VARC classification bleeding
6. • Type 3 VARC classification bleeding
7. • Fatal bleeding defined by Type 4 VARC classification
8. • Death
9. • Cardiovascular death
10. • Type 1 myocardial infarction based on the universal definition
11. • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury
12. • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury
13. • Transient cerebral ischemic attack defined by NeuroARC type 3a
14. • Any hospitalization
15. • Cardiovascular hospitalization
16. • VARC-defined prosthetic valve thrombosis
17. • VARC-3 defined Cardiovascular hospitalization
18. • Death at 2 years (national mortality database)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

Sponsor organisation

Centre Hospitalier Universitaire De Caen Normandie

Address

Avenue De La Cote De Nacre, Cs 30001 Cs 30001

City

Caen Cedex 9

Postcode

14033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

National coordinator

Public contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

National coordinator

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications