AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2024
  • participants needed
    1100
  • sponsor
    Columbia University
Updated on 26 April 2022
aspirin
heart disease
infarct
ischemic stroke
hemorrhagic stroke
brain imaging
recurrent strokes

Summary

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.

Description

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Details
Condition Stroke
Treatment Aspirin, Apixaban
Clinical Study IdentifierNCT03192215
SponsorColumbia University
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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