RECRUITING

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Description

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.

Study Overview

Study Details

Study overview

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.

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial

Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After Noncardiac Surgery

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Houston

Mcgovern Medical School at University of Texas, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 1. 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Population Health Research Institute,

David Conen, MD, MPH, PRINCIPAL_INVESTIGATOR, Population Health Research Institute

PJ Devereaux, MD, PhD, STUDY_CHAIR, Population Health Research Institute

Study Record Dates

2028-12