Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke (NCT05421533) | Clinical Trial Compass
TerminatedNot Applicable
Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke
Stopped: Concentration of resources on Phase 3 studies
United States, Argentina, Brazil705 participantsStarted 2022-09-14
Plain-language summary
The GARDENIA registry will collect real-world clinical data on the anticoagulant strategies in patients with AF at elevated risk of stroke but also elevated risk of bleeding.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent from the patient, or legally authorized representative, must be obtained before any assessment is performed
* Patients with diagnosed AF or atrial flutter(documented on an electrocardiogram or monitor recording)
* CHA2DS2-VASc score ≥2 excluding female as a factor
* Judged by the investigator to be at increased risk of bleeding because of at least 1 of the following:
* Age ≥70on the day of informed consent
* Reduced renal function (creatinine clearance \<30mL/min by Cockcroft-Gault)
* Chronic use of NSAIDs or antiplatelet agents
* Any other condition associated with increased risk such as a prior history of major or clinically relevant nonmajor bleeding, increased fall risk, or frailty
* Patients who are not treated with oral anticoagulants (only applies to the initial feasibility cohort)
Exclusion Criteria:
* Mechanical heart valve or valve disease that is expected to require valve replacement intervention (surgical or invasive) during the course of the registry study
* AF due to a reversible cause (eg, cardiac surgery, pulmonary embolism, untreated hyperthyroidism, ethanol use)
* Clinical unstable or active endocarditis or endovascular infection
* Patients with a medical condition other than AF for which chronic use of an oral anticoagulant is indicated
* History of left atrial appendage closure or removal
* Life expectancy \<1 year at the time of enrollment as assessed by the investigator
* Any medical or psychiatr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distribution of characteristics of patients with AF, including reasons anticoagulation is not used