Phase 4 Atrial Fibrillation Trial, Recruiting

Written by an AI model from 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 70 years or older
• People who have been diagnosed with atrial fibrillation (an irregular heart rhythm), confirmed by a heart tracing test (ECG or Holter monitor) showing an episode lasting at least 30 seconds within the past year
• People whose atrial fibrillation-related stroke risk score meets a minimum threshold — a score of 2 or more for men, or 3 or more for women, on a standard risk calculator called CHA2DS2-VASc
• People who are able to understand and sign a consent form agreeing to take part in the trial

Who may not be able to join:

• People with moderate-to-severe narrowing of the mitral heart valve, a previously implanted mechanical heart valve, an unremoved tumour in the heart (atrial myxoma), or a known blood clot in the left ventricle of the heart
• People who have had a biological heart valve replacement or heart valve repair surgery within the past 6 months
• People who have a mechanical heart pump device (left ventricular assist device) currently implanted
• People who have had a severe stroke within the past 3 months, or any stroke within the past 14 days (a severe stroke is defined as one leaving significant disability, such as needing help walking or with daily care)
• People who have had a mini-stroke (transient ischaemic attack, or TIA) within the past 3 days
• People whose atrial fibrillation was caused by a temporary, treatable trigger, such as recent heart surgery, a blood clot in the lungs, or an untreated overactive thyroid
• People who have previously had, or are planning to have within the next 3 months, a catheter ablation procedure, medication or electrical treatment to restore heart rhythm, or major surgery — or who have had a prior ablation more than 3 months ago but have no heart tracing records to confirm their current heart rhythm
• People who have previously had, or are planning to have, a procedure to close off the left atrial appendage (a small pouch in the heart)
• People with a current active heart valve infection (infective endocarditis)
• People with a high or increasing risk of bleeding, including any of the following:
  • Major surgery completed within the past 3 months or planned within the next 3 months
  • A previous serious bleed inside the skull, eye, spinal cord, behind the abdominal organs, or in a joint not caused by injury
  • A bleed in the digestive system within the past year
  • A stomach ulcer with symptoms, or one found on a stomach scope examination, within the past month
  • A blood clotting disorder or difficulty with normal clotting
  • Blood pressure that is very difficult to control (systolic above 180 mmHg and/or diastolic above 100 mmHg)
• People with severely reduced kidney function (confirm with trial site for specific test values)
• People with active liver disease, including persistently abnormal liver enzyme levels, elevated bilirubin, known active hepatitis A, B, or C, or cirrhosis (scarring of the liver)
• People with low haemoglobin (a measure of red blood cells in the blood) or a low platelet count (confirm with trial site for specific values)
• People who need anticoagulant (blood-thinning) medication for a reason other than atrial fibrillation, such as a blood clot condition
• People who need to take warfarin specifically for their condition
• People who take aspirin at a daily dose above 100mg
• People who have taken dual antiplatelet therapy (two blood-thinning medications together) or received antiplatelet drugs by injection within the past 5 days (note: taking a P2Y12 inhibitor alone, or aspirin alone at 100mg or less, may still be eligible — confirm with trial site)
• People who have received clot-dissolving (fibrinolytic) treatment within the past 10 days, or who are planning to use such treatment
• People who need to regularly take certain medications that can interact with the study drug, including specific antifungal medications, certain antibiotics, HIV treatments, heart medications, antidepressants (SSRIs or SNRIs), certain anti-seizure medications, or long-term non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (confirm with trial site for the full list)
• People who have a known allergy or intolerance to any ingredient in rivaroxaban tablets, including lactose or starch, or who have a hereditary condition affecting how the body processes these ingredients
• People diagnosed with a malignant (cancerous) tumour within the past 6 months, or who are currently receiving radiotherapy or chemotherapy, or whose life expectancy is estimated at 3 years or less
• People with antiphospholipid syndrome (an immune condition that affects blood clotting)
• People who are currently enrolled in, or have taken part in, another interventional clinical trial within the past 30 days
• People with a mental health condition, communication difficulties, cognitive impairment, or other serious health conditions that may affect their ability to participate fully in the trial
• People who are known to have difficulty following up with medical appointments or consistently taking study medications
• People whom the trial investigator considers unsuitable for enrolment for any other reason

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