Overview

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

Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
Summary
This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the efficacy and safety of rivaroxaban as compared to standard of care in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF and with low risk of stroke.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Montreal Heart Institute
Collaborators:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Canadian Institutes of Health Research (CIHR)
Canadian Stroke Prevention Intervention Network
Hewitt Foundation
Montreal Heart Institute Foundation
The Montreal Health Innovations Coordinating Center (MHICC)
Treatments:
Aspirin
Rivaroxaban
Criteria
For entry into the study, the following criteria must be met:

Inclusion Criteria:

- Age at consent ≥30 to ≤62 years;

- Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) documented by
any electrical tracing or any device (i.e. routine 12-lead electrocardiogram, Holter
monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or
pacemaker or implantable cardiac defibrillator interrogation of at least 30 s,
transcutaneous monitoring or other) in the last 2 years;

- 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 informed consent

For entry into the study, none of the following criteria MUST be met

Exclusion Criteria:

- Known diagnosis of dementia;

- MMSE score <25;

- Valvular AF [mechanical heart valve, moderate to severe mitral stenosis (rheumatic or
non rheumatic), 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);

- 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 randomization;

- 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);

- History of allergic reaction to rivaroxaban.

- History of allergic reaction, in the absence of desensitization to acetylsalicylic
acid in patients with vascular disease.