DIAMOND Study - DIrect oral anticoagulant for Antithrombotic Management Of aortic bioprothesis implanted patients for valvular heart Disease Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

13 Mar 2026 → ongoing

Decision date (initial)

2025-05-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Health Ministry

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

• To demonstrate that antithrombotic treatment with apixaban is superior to aspirin in patients with recent surgical bioprosthetic aortic valve replacement for the primary composite efficacy endpoint of death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis.

Secondary objectives 6

1. To compare apixaban with aspirin for bleeding (ISTH major bleeding)
2. To compare apixaban with aspirin for each endpoint of the primary efficacy endpoint
3. To compare apixaban with aspirin for a net clinical endpoint (primary efficacy and safety endpoints)
4. To compare apixaban with aspirin for cardiovascular death
5. To compare apixaban with aspirin for bleeding (ISTH major and non-major clinically relevant bleeding, Classification BARC 3 to 5 and TIMI major, minor and minimal bleeding)
6. To compare apixaban with aspirin mean aortic gradient (mmHg) and peak velocity (m/s)

Conditions and MedDRA coding

Aortic bioprothesis implanted patient for valvular heart disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Male or female ≥18 years of age
2. 2. Prior implantation of a bioprosthesis in the aortic position at least 7 days and before hospital discharge
3. 3. Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
4. 4. Patients affiliated to social security
5. 5. Patient able to give free, informed and written consent

Exclusion criteria 18

1. 1. Cardiac surgery less than 7 days prior to enrollment or more than 1 month
2. 2. Mechanical valve in any position or combined valve surgery (mitral or tricuspid).
3. 3. Any major bleeding in the three months (90 days) prior to enrollment.
4. 4. Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator
5. 5. Atrial fibrillation requiring chronic anticoagulation
6. 6. Need to be on dual antiplatelet therapy (aspirin >100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection).
7. 7. Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk).
8. 8. Creatinine clearance <40 mL/min (Cockcroft) or patients requiring apixaban dose reduction.
9. 9. Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure
10. 10. Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
11. 11. Ischemic stroke within 1 month or intracranial hemorrhage
12. 12. Active endocarditis at the time of screening for enrollment.
13. 13. Women of childbearing potential without efficient contraception, pregnant or breastfeeding women.
14. 14. Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
15. 15. History of non-compliance
16. 16. Participation in another interventional study
17. 17. Active cancer or life expectancy less than 1 year
18. 18. Persons deprived of their liberty by judicial or administrative decision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is a composite efficacy endpoint including death, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis. The primary endpoint will be evaluated at the end of the treatment (105±15 days after inclusion and randomization).

Secondary endpoints 8

1. Bleeding (primary safety endpoint) : ISTH major bleeding
2. Bleeding with ISTH bleeding scale : o ISTH major bleeding o ISTH non-major clinically relevant bleeding
3. Bleeding with the TIMI bleeding scale : o TIMI major bleeding o TIMI minor bleeding
4. Bleeding with the BARC definition (BARC 3 to 5)
5. Composite efficacy endpoints including: All-cause death, Myocardial infarction (Fourth Universal Definition of Myocardial Infarction), Stroke, Systemic embolism, Deep vein thrombosis, Pulmonary embolism, Valve thrombosis
6. All-cause death
7. Aortic valve thrombosis (adapted from VARC-3 definition)
8. Mean aortic gradient (mmHg) and peak velocity (m/s)

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Jean-Guillaume DILLINGER

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Jean-Guillaume DILLINGER

Locations

1 EU/EEA country · 26 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

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