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.