Can patients with atrial fibrillation discontinue anticoagulant therapy after cardiac surgery: The ATLAAC trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Feb 2024 → ongoing

Decision date (initial)

2023-06-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate the risk of stroke, systemic embolisms and major bleeding events with and without anticoagulant therapy in patients with atrial fibrillation, who have previously undergone surgical left atrial appendage closure

Secondary objectives 4

1. To investigate the mortality risk with and without anticoagulant therapy in patients with atrial fibrillation, who have previously undergone surgical left atrial appendage closure
2. To investigate the success of surgical left atrial appendage closure in patients, who have previously undergone cardiac surgery including surgical LAA closure
3. To evaluate and compare the procedural success of different techniques of surgical left atrial appendage closure
4. To evaluate and compare health-related quality of life in relation to discontinuing anticoagulant therapy

Conditions and MedDRA coding

Atrial fibrillation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age > 18 years
2. Previously undergone any type of cardiac surgical procedure including any type of surgical left atrial appendage closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the National Patient Register (NPR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 till April 1st 2023
3. Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
4. Informed consent

Exclusion criteria 5

1. Not receiving oral anticoagulant therapy (warfarin/DOAC)
2. Patient specific conditions requiring OAC (e.g. mechanical valve, previous pulmonary embolism)
3. Renal impairment (estimated glomerular filtration rate < 30)
4. Allergy to contrast media
5. Pregnancy or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Stroke, peripheral embolisms and major bleeding events (composite endpoint)

Secondary endpoints 18

1. Ischemic stroke
2. Hemorrhagic stroke
3. Severity of stroke according to Scandinavian Stroke Scale
4. Transient ischemic attack
5. Systemic embolism
6. All-cause stroke
7. All-cause mortality
8. Cardiovascular mortality
9. All types of bleeding leading to hospital contact
10. Blood transfusions
11. Myocardial infarction
12. Deep venous thrombosis
13. Pulmonary embolism
14. Length of the residual stump of the LAA
15. Volume of the residual stump of the LAA
16. Presence of contrast leakage across the closure line when relevant
17. Presence of thrombi in the LAA or the left atrium
18. Health-related quality of life scores

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Lars Peter Schødt Riber

Public contact point

Organisation

Odense University Hospital

Contact name

Lars Peter Schødt Riber

Third parties 1

Sponsor responsibilities

Article 77 compliance

Odense University Hospital

Contact point sponsor

Odense University Hospital

Article 77 implementation

Odense University Hospital

Locations

2 EU/EEA countries · 10 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 47 files

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

Application history

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