Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial

Phase 1

• Conditions: Perioperative atrial fibrillation after noncardiac surgery; MedDRA version: 22.1Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10005103Term: BleedingSystem Organ Class: 100000004866; MedDRA version: 20.0Level: LLTClassification code 10003663Term: Atrial flutter/ fibrillationSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001336-62-DK
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-18
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

Patients are eligible if they fulfill all of the following criteria:
1. have had noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
2. have had = one episode of clinically important perioperative AF during or after their surgery;
3. are in sinus rhythm at the time of randomization;
4. meet any of the following high-risk criteria; and
o age 55-74 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score = 3; or
o age = 75 years.
5. provide written informed consent to participate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 840
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1960

Exclusion Criteria

Patients are excluded if they meet any of the following criteria:
1. have a history of documented AF prior to noncardiac surgery; a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices) or a previous history of perioperative AF only (after cardiac or noncardiac surgery) are not exclusion criteria;
2. need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve);
3. have an ongoing need for long-term dual antiplatelet treatment;
4. have a contraindication to oral anticoagulation;
5. have severe renal insufficiency (eGFR < 30 ml/min);
6. have had an acute stroke in the past three months;
6. have had cardiac surgery in the past three months;
7. have a history of nontraumatic intracranial, intraocular, or spinal bleeding;
8. have hemorrhagic disorder or bleeding diathesis;
8. are expected to be non-compliant with follow-up and/or study medications;
9. have a known life expectancy less than one year due to concomitant disease;
10. are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; or
11. were previously enrolled in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 24 months after randomization. ;Secondary Objective: To assess the effects of NOACs on the incidence of the following outcomes 24 months after randomization: <br>1. individual components of the co-primary outcomes; <br>2. all-cause stroke; and <br>3. all-cause mortality. ;Primary end point(s): 1. Individual components of the co-primary outcomes; <br>2. All-cause stroke; and<br>3. All-cause mortality;Timepoint(s) of evaluation of this end point: When the last patient randomized has been followed for twenty-four months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. A composite of life-threatening, major, and critical organ bleeding; and<br>2. Major bleeding according to the International Society of Thrombosis and Hemostasis (ISTH) definition.;Timepoint(s) of evaluation of this end point: When the last patient randomized has been followed for twenty-four months