drugset / Trial / NCT04142125

Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease

NCT04142125 ↗

Phase 3 Completed 101 enrolled Population Health Research Institute
RandomizedParallel-groupSingle-blindTreatment

Summary

CATIS-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.

Timeline

Start
2020-02-03
Primary completion
2023-09-18
Completion
2023-09-18

Outcome

Missed primary endpoint

paper with a hazard ratio of 0.78 ([95% CI, 0.32-1.93]; P=0.59) favoring the intervention. PMID 39781748 ↗

paper A numerical trend toward efficacy for the composite primary end point of symptomatic ischemic stroke and covert infarcts was observed. PMID 39781748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 2.5 mg Oral
Background Acetylsalicyclic acid Unknown 81 mg —