What is the Purpose of this Study?
The purpose of this study is to determine whether long-term treatment with an approved blood thinner reduces the risk of stroke in patients who develop short-term atrial fibrillation after non-heart surgery, versus taking no blood thinner. Participants will be randomly assigned to either the “no oral anti-coagulant group” or the “non-vitamin K oral anticoagulation (blood thinner) group.” Patients who are assigned to the non-vitamin K oral anticoagulant group will receive either rivaroxaban or apixaban, as determined by their physician. These anticoagulants are approved by the U.S. Food and Drug Administration (FDA) for use in people with nonvalvular atrial fibrillation to reduce the risk of stroke and blood clots. It is currently unclear whether the drugs are also effective and safe in patients with short-term atrial fibrillation after surgery. Researchers will collect information about how often stroke, bleeding, and other blood vessel-related complications occur in patients who take these medications. The results of the study may be used to help create guidance for the use of blood thinners.
Eligibility
- 1. have ≥1 episode of clinically important AFOTS during any of the following conditions:
- 1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- 2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
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Inclusion Criteria:
- 1. have ≥1 episode of clinically important AFOTS during any of the following conditions:
- 1. noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
- 2. noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
- 3. acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
- 2. sinus rhythm at the time of randomization;
- 3. 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.;
- 4. provide written informed consent
Exclusion Criteria:
- 1. any cardiac diagnosis as the primary reason for hospital admission;
- 2. history of documented chronic AF prior to noncardiac surgery;
- 3. need for long-term systemic anticoagulation;
- 4. ongoing need for long-term dual antiplatelet treatment;
- 5. contraindication to oral anticoagulation;
- 6. severe renal insufficiency (CrCl \<20 ml/min);
- 7. severe liver cirrhosis (i.e., Child-Pugh Class C)
- 8. acute stroke in the past 14 days;
- 9. underwent cardiac surgery in the past 35 days;
- 10. history of nontraumatic intracranial, intraocular, or spinal bleeding;
- 11. hemorrhagic disorder or bleeding diathesis;
- 12. expected to be non-compliant with follow-up and/or study medications;
- 13. known life expectancy less than 1 year due to concomitant disease;
- 14. women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception; OR
- 15. previously enrolled in the trial
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Anticoagulation for Stroke Prevention In patients with Recent Episodes of perioperative Atrial Fibrillation after noncardiac surgery - The ASPIRE-AF trial