Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF "BRAIN-AF"


Phase 3 Results N/A

Eligibility Criteria

For entry into the study, the following criteria must be met:

Inclusion Criteria

- Age at consent ≥30 to ≤61 years
- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by any electrical tracing (routine 12-lead electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker or implantable cardiac defibrillator interrogation of at least 30 s) within the prior 18 months
- Low risk of stroke as defined by the absence of all of the following:
i. Prior stroke or Transient Ischemic Attack , ii. Hypertension, iii. Diabetes mellitus, iv. Congestive heart failure (New York Heart Association class II or higher at the time of enrolment or a known left ventricular ejection fraction <35%);
- Signed written informed consent
For entry into the study, none of the following criteria MUST be met

Exclusion Criteria

- Known diagnosis of dementia;
- Valvular AF (Clinically significant (severe or moderate) rheumatic mitral stenosis, mechanical or bioprosthetic heart valve, or mitral valve repair) or hypertrophic cardiomyopathy;
- Other indication for antiplatelet therapy or anticoagulation;
- History of GI bleeding;
- Conditions associated with an increased risk of bleeding described as follows:
1. Major surgery within the previous month;
2. Planned surgery or intervention within the next 3 months;
3. History of intracranial, intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding;
4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days;
5. Haemorrhagic disorder or bleeding diathesis;
6. Fibrinolytic agents within 48 hours of study entry;
7. Recent malignancy or radiation therapy (within 6 months from the time of enrolment) and not expected to survive 3 years;
- Reversible cause of AF (e.g. cardiac surgery, pulmonary embolism, untreated hyperthyroidism);
- Plan to perform pulmonary vein ablation or surgery for treatment of AF;
- Absence of recurrence of AF 3 months after AF ablation;
- Severe renal impairment (creatinine clearance 30 mL/min or less);
- Active infective endocarditis;
- Active liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine Transaminase (ALT) >3 times the upper limit of normal;
- Women who are pregnant or of childbearing potential not using a medically acceptable form of contraception throughout the study;
- Women who are breastfeeding;
- Anemia or thrombocytopenia (according to the normal range values of the local laboratory);
- Participation in another study involving an investigational drug (under development) at the same time or within 30 days of randomisation;
- Subjects considered unreliable, or having a life expectancy of less than 3 years or having any condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse);
- Known diagnosis of major depression within the past year.