AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (NCT03192215) | Clinical Trial Compass
TerminatedPhase 3
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Stopped: The DSMB halted the trial prematurely due to futility without any safety concerns.
United States1,015 participantsStarted 2018-01-19
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Number of Participants With Recurrent Stroke of Any Type