Phase 3 Stroke Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 22 and 85 years old
• People who speak English (Spanish-only speakers may be included at some trial sites in the future)
• People who have been diagnosed with atrial fibrillation (an irregular heartbeat) that is not permanent
• People whose stroke risk score (called CHA2DS2-VASc) falls within a specific moderate-risk range — between 1 and 4 for men, or between 2 and 4 for women — and who have never had a stroke or mini-stroke (TIA)
• People who are currently taking a type of blood-thinning medication called a DOAC (a newer type of anticoagulant, not warfarin) and are willing to remain on it for the study
• People who own a compatible iPhone with a current operating system and an active mobile data plan, are willing to wear a smartwatch for at least 14 hours a day, and expect to be within mobile network coverage at least 80% of the time
• People who are willing and able to stop taking their DOAC if instructed during the study
• People who are willing and able to give their informed consent to participate

Who may not be able to join:

• People who have valvular atrial fibrillation or permanent atrial fibrillation
• People currently taking warfarin who are unable or unwilling to switch to a DOAC
• People who are pregnant or breastfeeding
• People taking aspirin, other blood-thinning or anti-inflammatory medications (such as NSAIDs) on a long-term basis outside of accepted medical guidelines, and who are unwilling or unable to stop these during the study
• People who have an existing heart rhythm device (such as a pacemaker, defibrillator, or cardiac resynchronisation device), or who are planned to have one inserted — though insertable cardiac monitors are allowed unless they are being used to guide blood-thinning treatment
• People whose atrial fibrillation episodes are known or suspected to last 1 hour or more per month over the past 3 months
• People who have had a single atrial fibrillation episode lasting 1 hour or more, detected on a heart monitor worn for more than 6 days, within the 45 days before joining the study (shorter monitoring periods may be considered — confirm with trial site)
• People who have had a procedure (ablation) to treat atrial fibrillation within the last 2 months
• People who have previously had, or are expected to have, a procedure to close or tie off the left atrial appendage (a small pouch in the heart)
• People with mechanical heart valves or severe heart valve disease
• People with a heart muscle condition called hypertrophic cardiomyopathy
• People who need blood-thinning medication for reasons other than atrial fibrillation-related stroke prevention (such as for blood clots in the legs or lungs, congenital heart conditions, or prosthetic heart valves)
• People considered by their doctor to be at high risk of stroke from causes unrelated to atrial fibrillation, such as significant narrowing of the neck arteries (more than 75% blockage)
• People currently enrolled in, recently participated in (within the last 30 days), or planning to join another clinical drug or device study — unless pre-approval has been granted by the study manager
• People who have a tattoo, birthmark, or surgical scar on the wrist area where the study smartwatch would be worn
• People who have a tremor in the arm or wrist where the study smartwatch would be worn
• People with any other condition that the investigator believes would make participation unsafe, such as drug or alcohol dependency
• People with a known allergy or medical reason to avoid DOAC medications
• People who have previously had a stroke (any type) or a mini-stroke (TIA)
• People whose atrial fibrillation was caused by a reversible condition, such as heart surgery, a blood clot in the lungs, or an untreated thyroid condition
• People whose heart monitoring shows a high level (more than 5%) of abnormal heartbeats from the upper or lower chambers of the heart
• People with a history of a related heart rhythm problem called atrial flutter, unless it has already been treated with an ablation procedure
• People with stage 4 or 5 chronic kidney disease
• People with conditions that increase the risk of serious bleeding, including: major surgery in the past month; planned surgery within the next three months requiring more than 2 weeks off blood thinners; a history of bleeding in the brain, eye, spine, or certain internal areas; a gastrointestinal bleed within the past year (unless the cause has been permanently resolved); a stomach or duodenal ulcer in the past 30 days; a bleeding disorder; a need for blood thinners for reasons other than atrial fibrillation; or severely uncontrolled high blood pressure (systolic above 180 mmHg and/or diastolic above 100 mmHg)

Important: Always verify eligibility with the trial site directly before applying.