Anticoagulation for Stroke Prevention In patients with Recent Episodes of Atrial Fibrillation occurring transiently with stress

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hamilton Health Sciences Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

29 Jan 2024 → ongoing

Decision date (initial)

2025-02-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Canadian Institute of Health Research

External identifiers

EU CT number

2023-509142-35-00

EudraCT number

2019-001336-62

ClinicalTrials.gov

NCT03968393

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the effects of non-vitamin K oral anticoagulants (NOACs) versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.

Secondary objectives 3

1. To assess the effects of NOACs on the incidence of individual components of the co-primary outcomes
2. To assess the effects of NOACs on the incidence of all stroke
3. To assess the effects of NOACs on the incidence of all-cause mortality.

Conditions and MedDRA coding

Atrial fibrillation after stress (e.g., noncardiac surgery or acute medical illness)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. have at least 1 episode of clinically important AFOTS during any of the following conditions: noncardiac surgery in the past 35 days, with at least an overnight hospital admission after surgery; noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator
2. Are in sinus rhythm at the time of randomization
3. Meet any of the following high-risk criteria; (1) age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥ 3, or an elevated postoperative troponin level; (2) age 65-74 years, and having either established cardiovascular disease, recent vascular surgery, a CHA2DS2VASc score ≥ 2, or an elevated postoperative troponin level; or (3) age ≥ 75 years
4. Provide written informed consent to participate

Exclusion criteria 15

1. Have a history of documented chronic (i.e., non-transient) AF prior to noncardiac surgery. For example, the following patients will still be considered eligible for this trial: (1) a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices); (2) a previous history of perioperative AF only (after cardiac or noncardiac surgery); or (3) patients with a previous history of transient AF after medical stress (e.g., sepsis, uncontrolled hyperthyroidism)
2. Have an ongoing need for long-term dual antiplatelet treatment
3. Have a contraindication to oral anticoagulation
4. Have severe renal insufficiency (CrCl < 20 ml/min)
5. Have had an acute stroke in the past 14 days
6. any cardiac diagnosis as the primary reason for hospital admission (e.g., acute coronary syndrome, congestive heart failure, peri-myocarditis)
7. Have had cardiac surgery in the past 35 days
8. Have a history of nontraumatic intracranial, intraocular, or spinal bleeding
9. Are expected to be non-compliant with follow-up and/or study medications
10. Have severe liver cirrhosis (i.e., Child-Pugh Class C)
11. Have a known life expectancy less than one year due to concomitant disease
12. Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception
13. Were previously enrolled in the trial
14. Need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve, antiphospholipid syndrome with a history of thrombosis))
15. hemorrhagic disorder or bleeding diathesis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Individual components of the co-primary outcomes
2. All stroke
3. All-cause mortality

Investigational products

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

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hamilton Health Sciences Corporation

Sponsor organisation

Hamilton Health Sciences Corporation

Address

100 King Street West

City

Hamilton

Postcode

L8P 1A2

Country

Canada

Scientific contact point

Organisation

Hamilton Health Sciences Corporation

Contact name

Dr. David Conen

Public contact point

Organisation

Hamilton Health Sciences Corporation

Contact name

Dr. David Conen

Third parties 1

Locations

10 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 5 · Art. 77 CTR

Results and documents

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

Documents 50 files

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

Application history

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