AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Stroke

In brief

Objectives * Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. * Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Key facts

Study ID

NCT03192215

Run by

Columbia University

People needed

1015

Starts

2018-01-19

Expected to finish

2023-04-17

Last updated by the study team

2025-04-09

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 45 years.
• Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
• Modified Rankin Scale (MRS) score ≤ 4.
• Ability to be randomized within 3 to 180 days after stroke onset.
• ESUS, defined as all of the following:
• Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
• Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
• No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
• No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.

You may not qualify if…

• History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
• Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
• Need for antiplatelet agent, such as aspirin or clopidogrel
• History of spontaneous intracranial hemorrhage.
• Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
• Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
• Clinically significant bleeding diathesis.
• Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
• Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
• At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
• Known allergy or intolerance to aspirin or apixaban.
• Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
• Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
• Inability of either participant or surrogate to provide written, informed consent for trial participation.
• To be eligible for randomization, consented participants must meet criteria for atrial cardiopathy in addition to the inclusion/exclusion criteria above.
• Atrial cardiopathy is defined as ≥1 of the following:
• PTFV1 >5,000 μV*ms on 12-lead ECG (ECG criterion).
• Serum NT-proBNP >250 pg/mL (NT-proBNP criterion).
• Left atrial diameter index ≥3 cm/m2 on echocardiogram (i.e., severe left atrial enlargement) (ECHO criterion)

Where it is running

• University of South Alabama University Hospital — Mobile, Alabama, United States
• Chandler Regional Medical Center Chandler, AZ — Chandler, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Mercy San Juan Medical Center (Dignity Health) — Carmichael, California, United States
• Eden Medical Center — Castro Valley, California, United States
• Rancho Los Amigos National Rehabilitation Center — Downey, California, United States
• Fountain Valley Regional Hospital and Medical Center — Fountain Valley, California, United States
• Community Regional Medical Center — Fresno, California, United States
• UCSD Health La Jolla — La Jolla, California, United States
• Sharp Grossmont Hospital — La Mesa, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Los Alamitos Medical Center — Los Alamitos, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Keck Hospital Of USC — Los Angeles, California, United States
• Los Angeles County- USC Medical Center — Los Angeles, California, United States
• VA Greater Los Angeles - West LA VA Medical Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Sutter Medical Center — Sacramento, California, United States
• Salinas Valley Memorial Hospital — Salinas, California, United States
• Scripps Mercy — San Diego, California, United States
• UCSD Medical Center - Hillcrest Hospital — San Diego, California, United States
• Kaiser Permanent San Diego Medical Center — San Diego, California, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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