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Clinical Trials in Mexico / NCT03907046
Recruiting Phase 3

Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

NCT03907046 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2020-01-28
Last updated
2026-05-08

Condition(s) studied

Intracerebral HemorrhageAtrial Fibrillation

Investigational drug(s) / intervention(s)

Apixaban →Aspirin →

Apixaban: Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.

Aspirin: Aspirin is an oral antiplatelet drug.

Study summary

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age at least 18 years * Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI * Can be randomized within 14-180 days after ICH onset * Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF * Provision of signed and dated informed consent form by patient or legally authorized representative * For females of reproductive potential: use of highly effective contraception Exclusion Criteria: * Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor * History of earlier ICH within 12 months preceding index event * Active infective endocarditis * Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent). * Previous or planned left atrial appendage closure * Clinically significant bleeding diathesis * Serum creatinine ≥2.5 mg/dL * Active hepatitis or hepatic insufficiency with Child-Pugh score B or C * Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator * Pregnant or breastfeeding * Known allergy to aspirin or apixaban * Concomitant participation in a competing trial * Considered by the investigator to have a condition that precludes safe or active participation in the trial * Persistent, uncontrolled systolic blood pressure (≥180 mm Hg) * ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Primary outcome measure(s)

Trial sites (187)

FacilityCityRegionStatus
University of Alabama Hospital Birmingham Alabama Recruiting
University of South Alabama University Hospital Mobile Alabama Recruiting
Chandler Regional Medical Center Chandler Arizona Withdrawn
St. Joseph's Hospital and Medical Center Phoenix Arizona Withdrawn
Banner University Medical Center Tucson Arizona Recruiting
UAMS Medical Center Little Rock Arkansas Withdrawn
Mercy San Juan Medical Center Carmichael California Recruiting
Eden Medical Center, Castro Valley Castro Valley California Withdrawn
Arrowhead Regional Medical Center Colton California Recruiting
Rancho Los Amigos National Rehabilitation Center Downey California Suspended
Kaiser Permanente Fontana Medical Center Fontana California Recruiting
Community Regional Medical Center of Fresno Fresno California Recruiting
St. Jude Medical Center Fullerton California Recruiting
Long Beach Memorial Medical Center Long Beach California Withdrawn
Los Alamitos Medical Center Los Alamitos California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Ronald Reagan UCLA Medical Center Los Angeles California Recruiting
Doctors Medical Center Modesto, Modesto, CA Modesto California Recruiting
Hoag Hospital Newport Beach Newport Beach California Withdrawn
UC Irvine Medical Center Orange California Recruiting
Desert Regional Medical Center Palm Springs California Recruiting
Huntington Memorial Hospital Pasadena California Withdrawn
Kaiser Permanente Redwood City Medical Center, Redwood City, CA Redwood City California Recruiting
UC Davis Medical Center Sacramento California Recruiting
Kaiser Permanente Sacramento Medical Center Sacramento California Recruiting
San Francisco General Hospital San Francisco California Recruiting
Santa Barbara Cottage Hospital Santa Barbara California Recruiting
Stanford University Medical Center Stanford California Recruiting
PIH Health Hospital - Whittier Whittier California Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
St. Mary's Medical Center Grand Junction Colorado Withdrawn
Danbury Hospital Danbury Connecticut Suspended
Hartford Hospital Hartford Connecticut Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
New Hanover Regional Medical Center Wilmington Delaware Recruiting
MedStar Georgetown University Hospital Washington D.C. District of Columbia Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Withdrawn
George Washington University Hospital Washington D.C. District of Columbia Recruiting
Morton Plant Hospital Clearwater Florida Recruiting

+ 147 more sites — see the full list on the official registry below.

On this site

📄 Eliquis (apixaban) drug profile →

More Yale University trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03907046 on ClinicalTrials.gov ↗ ← All trials in Mexico