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

Launched by POPULATION HEALTH RESEARCH INSTITUTE · May 27, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at whether taking blood-thinning medication (called anticoagulants) can help prevent strokes in patients who have experienced temporary atrial fibrillation (AF) after having non-heart surgery. Atrial fibrillation is a condition where the heart beats irregularly, and it can increase the risk of strokes. The study will compare patients who take these medications to those who do not, focusing on those who had surgery within the last 35 days and had at least one episode of significant AF during or after their procedure.

To be eligible for the trial, participants should be at least 55 years old and have specific risk factors, like a history of heart problems or elevated troponin levels (a marker of heart stress), or they should be 65 years or older. Participants will need to provide written consent and will be monitored during the study to assess the effects of the anticoagulants on their health. This trial is currently recruiting participants of all genders, and it aims to gather important information that could help improve safety and care for patients at risk of stroke after surgery.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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