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Anticoagulation for Stroke Prevention In patients with Recent Episodes of Atrial Fibrillation occurring transiently with stress
EU CTIS ID: 2023-509142-35-00
What this study is testing
To assess the effects of non-vitamin K oral anticoagulants (NOACs) versus no anticoagulation on the co-primary composite outcomes of 1. non-hemorrhagic stroke and systemic embolism, and 2. vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism over the duration of follow-up.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- have at least 1 episode of clinically important AFOTS during any of the following conditions: noncardiac surgery in the past 35 days, with at least an overnight hospital admission after surgery; noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or 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
- Are in sinus rhythm at the time of randomization
- Meet any of the following high-risk criteria; (1) age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥ 3, or an elevated postoperative troponin level; (2) age 65-74 years, and having either established cardiovascular disease, recent vascular surgery, a CHA2DS2VASc score ≥ 2, or an elevated postoperative troponin level; or (3) age ≥ 75 years
- Provide written informed consent to participate
You likely can't join if
- Have a history of documented chronic (i.e., non-transient) AF prior to noncardiac surgery. For example, the following patients will still be considered eligible for this trial: (1) a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices); (2) a previous history of perioperative AF only (after cardiac or noncardiac surgery); or (3) patients with a previous history of transient AF after medical stress (e.g., sepsis, uncontrolled hyperthyroidism)
- Have severe liver cirrhosis (i.e., Child-Pugh Class C)
- Have a known life expectancy less than one year due to concomitant disease
- Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception
- Were previously enrolled in the trial
- Need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve, antiphospholipid syndrome with a history of thrombosis))
See the full eligibility criteria
- have at least 1 episode of clinically important AFOTS during any of the following conditions: noncardiac surgery in the past 35 days, with at least an overnight hospital admission after surgery; noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or 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
- Are in sinus rhythm at the time of randomization
- Meet any of the following high-risk criteria; (1) age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2VASc score ≥ 3, or an elevated postoperative troponin level; (2) age 65-74 years, and having either established cardiovascular disease, recent vascular surgery, a CHA2DS2VASc score ≥ 2, or an elevated postoperative troponin level; or (3) age ≥ 75 years
- Provide written informed consent to participate
- Have a history of documented chronic (i.e., non-transient) AF prior to noncardiac surgery. For example, the following patients will still be considered eligible for this trial: (1) a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices); (2) a previous history of perioperative AF only (after cardiac or noncardiac surgery); or (3) patients with a previous history of transient AF after medical stress (e.g., sepsis, uncontrolled hyperthyroidism)
- Have severe liver cirrhosis (i.e., Child-Pugh Class C)
- Have a known life expectancy less than one year due to concomitant disease
- Are women who are pregnant, breastfeeding, or of childbearing potential who are not taking effective contraception
- Were previously enrolled in the trial
- Need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve, antiphospholipid syndrome with a history of thrombosis))
- hemorrhagic disorder or bleeding diathesis
- Have an ongoing need for long-term dual antiplatelet treatment
- Have a contraindication to oral anticoagulation
- Have severe renal insufficiency (CrCl < 20 ml/min)
- Have had an acute stroke in the past 14 days
- any cardiac diagnosis as the primary reason for hospital admission (e.g., acute coronary syndrome, congestive heart failure, peri-myocarditis)
- Have had cardiac surgery in the past 35 days
- Have a history of nontraumatic intracranial, intraocular, or spinal bleeding
- Are expected to be non-compliant with follow-up and/or study medications
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Australia
- Pakistan
- Brazil
- Korea, Republic of
- United Kingdom
- India
- Argentina
- United States
- Canada
- Nepal
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Australia; Pakistan; Brazil; Korea, Republic of; United Kingdom and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.