Study info

Atrial Fibrillation (AFIB)

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Atrial Fibrillation (AFIB)

Start date:

June 5, 2023

Study duration:

11 Onsite visits over approximately a 2 year period.

Compensation (per visit):


Total compensation:

  1. Age: Participants must be at least 18 years old (or the legal age of consent in their jurisdiction).
  2. Medically stable: Participants should be in a stable condition and suitable for chronic antithrombotic treatment based on physical examination, medical history, vital signs, and clinical laboratory tests.
  3. Atrial Fibrillation or Flutter: Participants must have documented evidence of atrial fibrillation or flutter, not due to a reversible cause, and be eligible for anticoagulation therapy.
  1. Risk Factors: Participants must meet one or both of the following risk factor categories:
    a) One or more risk factors, such as age ≥75 years or a history of symptomatic stroke.
    b) Two or more risk factors, including age between 65 and 74 years, hypertension, diabetes mellitus, atherosclerotic vascular disease, or symptomatic heart failure.
  1. Recent Stroke: Participants who had an ischemic stroke within 7 days or any hemorrhagic stroke, subarachnoid hemorrhage, subdural hematoma, or spinal cord hemorrhage within 3 months before randomization.
  2. Disabling Stroke: Participants with a current mRS score of ≥3 indicating a disabling stroke.
  3. Hemodynamically Significant Valve Disease: Participants with valve disease that may require surgical valve replacement during the study.
  4. Contraindications to Anticoagulation: Participants with conditions contraindicating anticoagulant therapy or posing an unacceptable risk of bleeding.
  5. Atrial Myxoma or Left Ventricular Thrombus: Participants with a known presence of atrial myxoma or left ventricular thrombus.
  6. Active Liver Disease: Participants with current active liver disease or receiving antiviral treatment for hepatitis.
  7. Renal Dysfunction: Participants requiring dialysis or with an eGFR <25 mL/min/1.73 m2 at screening.
  8. Drug Allergies: Participants with a history of significant drug allergies.
  9. Acute Heart Failure: Participants hospitalized for acute heart failure at the time of randomization.
  10. Milvexian Allergy: Participants with known allergies, hypersensitivity, or intolerance to milvexian or its excipients.
  11. Inability to Swallow Medications: Participants unable to swallow medications.
  12. Disallowed Therapies: Participants planning to use disallowed therapies as specified in the study protocol.
  13. Recent Investigational Intervention: Participants who received an investigational intervention or used an invasive investigational medical device within 4 weeks before the planned first dose of study intervention or are currently enrolled in an investigational interventional study.
  14. Abnormal Laboratory Results: Participants with abnormal laboratory results outside specified ranges for platelet count, ALT, total bilirubin, or hemoglobin.
  15. Other Criteria: Participants who, in the opinion of the investigator, would not benefit from study participation, may confound the assessments, or have a life expectancy of less than 12 months.
  16. Non-compliance: Participants who will not follow the study contact schedule or allow contact for determining endpoint events and vital status.
  17. Incarceration: Participants who are incarcerated or compulsorily detained for treatment of psychiatric disease.
  18. Substance Abuse: Participants with known current substance abuse that could impact study compliance.
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Completed Studies
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Principal Investigators
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Year Experience