Comparison between single and dual therapy with drugs that inhibits platelet aggregation in patient undergoing the percutaneous left atrial appenDAge closure (ARMYDA-AMULET in which people will be allocated by chance to receive two different options of treatment and which will involves different clinical sites)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Toscana Gabriele Monasterio

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

13 Oct 2021 → ongoing

Decision date (initial)

2024-09-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515361-34-00

EudraCT number

2021-000730-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate that the strategy with single antiplatelet therapy (SAPT) is not inferior to the current standard antiplatelet therapy (DAPT) after LAA closure regarding the cumulative incidence of the net composite endpoint, including death, thrombotic complications and bleeding events, at 6 months.

Secondary objectives 1

1. Compared to DAPT, SAPT use is associated with a similar incidence of ischemic events and a significantly lower incidence of bleeding complications at 6 months.

Conditions and MedDRA coding

Patients with atrial fibrillation undergoing percutaneous left atrial appendage closure with the Amulet device

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Men or women aged =18 years signing a specific informed consent
2. Patients with a planned percutaneous LAA closure
3. Patients with documented non-valvular AF, irrespective of the type (paroxysmal, permanent, persistent), and CHA2DS2-VASc score =2
4. Patients suitable for treatment with aspirin and clopidogrel according to the Summaries of product characteristics (SmPCs)
5. Patients considered unsuitable for long-term oral anticoagulant therapy due to a high bleeding risk. Patients will be judged unsuitable for anticoagulation because of bleeding-prone comorbidities, history of previous bleeding (with or without anticoagulant treatment) or an expected low adherence to therapy
6. Patient’s availability to undergo the follow-up visits scheduled for the study
7. Negative pregnancy testing (if applicable), performed at the time of enrollment

Exclusion criteria 19

1. CHADS-VAsc score 0-1
2. Requirement for on-going therapy with clopidogrel at the time of screening evaluation (e.g. current therapy with clopidogrel at the time of the screening evaluation will be an exclusion criterion)
3. Known hypersensitivity to the study drugs (aspirin or clopidogrel)
4. Patients deemed to be unsuitable for at least 6 months antiplatelet therapy (SAPT or DAPT) because of a recent (<1 month) major bleeding event
5. Planned oral anticoagulant therapy after the procedure
6. Moderate to severe mitral stenosis
7. Mechanical heart prosthetic valve
8. Active endocarditis
9. Active bleeding
10. Myocardial infarction or percutaneous coronary intervention <6 months
11. Major surgery within one month
12. Intracranial neoplasm, aneurysm or arterio-venous malformation
13. Platelet count <50,000/µL
14. Recent stroke (<1 month)
15. Fibrinolytic therapy within 10 days
16. Baseline hemoglobin <9 g/dL
17. Pregnant woman
18. Breast-feeding
19. Donne fertili impossibilitate ad utilizzare contraccettivi durante lo studio

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary endpoint will be the 6-month incidence in the two arms (SAPT versus DAPT) of the net composite endpoint including all-cause death, DRT (at 3- or 6-month TEE), ischemic stroke, systemic embolic events (SEE) or BARC classification bleeding ≥3 (7).

Secondary endpoints 5

1. DRT at 3 and 6 months by TEE
2. Any-cause death
3. Incidence of ischemic stroke or SEE at 3 and 6 months
4. Incidence of any bleeding at 3 and 6 months
5. Incidence of BARC classification bleeding ≥3 at 3 and 6 months

Investigational products

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

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Toscana Gabriele Monasterio

Sponsor organisation

Fondazione Toscana Gabriele Monasterio

Address

Via Trieste 41

City

Pisa

Postcode

56126

Country

Italy

Scientific contact point

Organisation

Fondazione Toscana Gabriele Monasterio

Contact name

Stefania Biagini

Public contact point

Organisation

Fondazione Toscana Gabriele Monasterio

Contact name

Stefania Biagini

Third parties 1

Locations

1 EU/EEA country · 19 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 8 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