No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
2,270 (estimated)
Sponsor
Population Health Research Institute · Other
Who this trial is looking for
This trial is looking for people who have had recent episodes of atrial fibrillation caused by stress. Participants will be involved in comparing anticoagulation treatment with no treatment to see which is better for preventing strokes.
Are You a Good Fit for This Trial?
You may be able to join if
I have had at least one episode of atrial fibrillation due to stress.
I am in sinus rhythm at the time of joining the trial.
I am aged 55 or older with other health risks.
You may not be able to join if
I was admitted to the hospital for a heart condition.
I have a history of chronic atrial fibrillation before surgery.
I need long-term blood thinning treatment.
I have severe kidney or liver problems.
I had a stroke in the past 14 days.
I have a history of serious bleeding issues.
I am pregnant, breastfeeding, or not using effective contraception.
I expect to have trouble following the trial instructions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
Trial Locations
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City
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Status
Eligibility Criteria
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…
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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