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

Phase 1

• Conditions: Atrial Fibrillation perioperative after noncardiac surgery; MedDRA version: 20.0Level: LLTClassification code 10016566Term: Fibrillation atrialSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-001336-62-IT
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

Patients are eligible if they: 1. underwent noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
2. have had =1 episode of clinically important perioperative atrial fibrillation or flutter (AF);
3. are in sinus rhythm at the time of randomization;
4. have any of the following high-risk criteria: a. age 55-74 years plus either established cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score =3; or b. age =75 years;
5.provide written informed consent
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients are excluded if they fulfill any of the following criteria: 1. have a history of documented AF before noncardiac surgery; 2. need long-term therapeutic anticoagulation (e.g., mechanical valve); 3. ongoing need for long-term dualantiplatelet treatment; 4. have a contraindication to anticoagulation; 5. have severe renal insufficiency (i.e., eGFR <30 ml/min); 6. have had an acute stroke in the preceding 3 months; 7. underwent cardiac surgery in the preceding 3 months; 8.have a history of intracranial, intraocular, or spinal bleeding; 9. have hemorrhagic disorder or bleeding diathesis; 10. are expected to be non-compliant with follow-up;11. have a known life expectancy of <1 year due to concomitant disease; 12. women who are pregnant, breastfeeding, or of childbearing potential and not taking effective contraception; or 13. were previously enrolled in the trial

Study & Design

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