Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery
Purpose
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
Conditions
- Stroke
- Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- noncardiac surgery in the past 35 days with at least one of the following: 1. an overnight hospital admission after surgery; 2. day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator 2. ≥1 episode of clinically important perioperative AF during or after their surgery; 3. sinus rhythm at the time of randomization; AND 4. 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. 5. provide written informed consent
Exclusion Criteria
- history of documented chronic AF prior to noncardiac surgery; 2. need for long-term systemic anticoagulation; 3. ongoing need for long-term dual antiplatelet treatment; 4. contraindication to oral anticoagulation; 5. severe renal insufficiency (CrCl <20 ml/min); 6. severe liver cirrhosis (i.e., Child-Pugh Class C) 7. acute stroke in the past 14 days; 8. underwent cardiac surgery in the past 35 days; 9. history of nontraumatic intracranial, intraocular, or spinal bleeding; 10. hemorrhagic disorder or bleeding diathesis; 11. expected to be non-compliant with follow-up and/or study medications; 12. known life expectancy less than 1 year due to concomitant disease; 13. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR 14. previously enrolled in the trial
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective, randomized, open-label clinical trial with blinded outcome assessment
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Mcgovern Medical School at University of Texas
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Population Health Research Institute
Detailed Description
ASPIRE-AF is a prospective, randomized, open-label trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with transient perioperative atrial fibrillation and additional stroke factors after noncardiac surgery. The primary objective is to assess the effects of 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.