Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03968393
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT03968393
Study Brief:
Protocol Section:
NCT03968393