Study info
Atrial Fibrillation (AFIB)
Overview
Indication:
Atrial Fibrillation (AFIB)
Start date:
June 5, 2023
Study duration:
11 Onsite visits over approximately a 2 year period.
Compensation (per visit):
$92
Total compensation:
$1012
- Age: Participants must be at least 18 years old (or the legal age of consent in their jurisdiction).
- 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.
- 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.
- 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.
- 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.
- Disabling Stroke: Participants with a current mRS score of ≥3 indicating a disabling stroke.
- Hemodynamically Significant Valve Disease: Participants with valve disease that may require surgical valve replacement during the study.
- Contraindications to Anticoagulation: Participants with conditions contraindicating anticoagulant therapy or posing an unacceptable risk of bleeding.
- Atrial Myxoma or Left Ventricular Thrombus: Participants with a known presence of atrial myxoma or left ventricular thrombus.
- Active Liver Disease: Participants with current active liver disease or receiving antiviral treatment for hepatitis.
- Renal Dysfunction: Participants requiring dialysis or with an eGFR <25 mL/min/1.73 m2 at screening.
- Drug Allergies: Participants with a history of significant drug allergies.
- Acute Heart Failure: Participants hospitalized for acute heart failure at the time of randomization.
- Milvexian Allergy: Participants with known allergies, hypersensitivity, or intolerance to milvexian or its excipients.
- Inability to Swallow Medications: Participants unable to swallow medications.
- Disallowed Therapies: Participants planning to use disallowed therapies as specified in the study protocol.
- 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.
- Abnormal Laboratory Results: Participants with abnormal laboratory results outside specified ranges for platelet count, ALT, total bilirubin, or hemoglobin.
- 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.
- Non-compliance: Participants who will not follow the study contact schedule or allow contact for determining endpoint events and vital status.
- Incarceration: Participants who are incarcerated or compulsorily detained for treatment of psychiatric disease.
- Substance Abuse: Participants with known current substance abuse that could impact study compliance.
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