Recruiting

Anticoagulation vs. No Anticoagulation

Sponsor:

Population Health Research Institute

Code:

NCT03968393

Conditions

Stroke

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Non-vitamin K oral anticoagulant (NOAC)

Study Details

Brief summary:

Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.

Conditions

Stroke

Atrial Fibrillation

Study ID

NCT03968393

Start date

Jun 14, 2019

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. have ≥1 episode of clinically important AFOTS during any of the following conditions:

1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
3. 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. sinus rhythm at the time of randomization;
3. any of the following high-risk criteria:

1. age 55-64 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥3, or an elevated postoperative troponin level;
2. age 65-74 years, and having either known cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥2, or an elevated postoperative troponin level; OR
3. age ≥75 years.;
4. provide written informed consent

Exclusion Criteria:

1. any cardiac diagnosis as the primary reason for hospital admission;
2. history of documented chronic AF prior to noncardiac surgery;
3. need for long-term systemic anticoagulation;
4. ongoing need for long-term dual antiplatelet treatment;
5. contraindication to oral anticoagulation;
6. severe renal insufficiency (CrCl <20 ml/min);
7. severe liver cirrhosis (i.e., Child-Pugh Class C)
8. acute stroke in the past 14 days;
9. underwent cardiac surgery in the past 35 days;
10. history of nontraumatic intracranial, intraocular, or spinal bleeding;
11. hemorrhagic disorder or bleeding diathesis;
12. expected to be non-compliant with follow-up and/or study medications;
13. known life expectancy less than 1 year due to concomitant disease;
14. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
15. previously enrolled in the trial

Study Design

Enrollment

2270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Non-vitamin K oral anticoagulant (NOAC)

Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up, unless they are undergoing a procedure with an increased risk of bleeding, have an adverse event or low calculated creatinine clearance, or decide to discontinue their use.

no intervention: No anticoagulation

Participants randomized to the control arm will not be prescribed an oral anticoagulant unless they develop a clear indication for one during follow-up (e.g., recurrent nonoperative AF). They can be newly prescribed or continue taking low dose aspirin or another single antiplatelet agent as per the protocol. This will be decided by the participant's physician.

Interventions

Non-vitamin K oral anticoagulant (NOAC)

Participants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.

Primary outcome measure

  • Incidence of Non-hemorrhagic stroke or systemic embolism [ Time Frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) ]
  • Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism [ Time Frame: For the duration of follow-up, until final follow-up (occurs when the last global participant has been followed for 24 months) ]

Central Contacts and Locations

Central contacts

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Eric Braunstein, MD

Mcgovern Medical School at University of Texas

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Sanjana Malviya, MD

Foothills Hospital

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Principal Investigator:

Shannon Ruzycki, MD

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Principal Investigator:

Finlay McAlister, MD

Medicine Hat Regional Hospital

Recruiting

Medicine Hat, Alberta, Canada, T1A 4H6

Principal Investigator:

Herbert Manosalva, MD

Fraser Health Authority

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Principal Investigator:

Mark Warwas, MD

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1N1

Principal Investigator:

Mihalio Veljovic, MD

Health Sciences Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Principal Investigator:

Sadeesh Srinathan, MD

Halifax Infirmary

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A6

Principal Investigator:

Kim Styles, MD

Cape Breton University

Recruiting

Sydney, Nova Scotia, Canada, B1M 1A2

Principal Investigator:

Paul MacDonald, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Mohamed Panju, MD

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Principal Investigator:

Vikas Tandon, MD

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Principal Investigator:

Ameen Patel, MD

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Principal Investigator:

Stephanie Sibley, MD

London Health Sciences Centre - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Principal Investigator:

Marko Mrkobrada, MD

The Ottawa Hospital General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Principal Investigator:

James Villeneuve, MD

Niagara Health System - St. Catharine's Site

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Principal Investigator:

Leonard Blair, MD

Cortelluci Vaughan Hospital

Recruiting

Vaughan, Ontario, Canada, L6A 4Z3

Principal Investigator:

Courtney Anne Scott, MD

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Principal Investigator:

Isabelle Greiss, MD

Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Principal Investigator:

Félix Ayala-Paredes, MD

Regina General Hospital

Recruiting

Regina, Saskatchewan, Canada, S4P 0W5

Principal Investigator:

Payam Dehghani, MD

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Principal Investigator:

Michael Prystajecky, MD

More Information

Sponsor

Population Health Research Institute

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

  • Transient Atrial Fibrillation
  • Perioperative Atrial Fibrillation
  • Non-vitamin K Oral Anticoagulation
  • Noncardiac Surgery
  • PROBE Design
  • Medical Illness
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2026-01-12.