drugset / Trial / NCT04219774

NeuroCognition After Carotid Recanalization

NCT04219774

Phase 2 Completed 25 enrolled Duke University
RandomizedParallel-groupSingle-blindTreatment

Summary

Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes per year in the US an incidence more than twice the annual occurrence of ruptured intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3). Symptomatic COICA subjects are at increased risk of developing cognitive impairment and progressive development of vascular dementia and AD with time. Our proposal leverages several compelling retrospective and prospective preliminary data from human to perform this exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated

Timeline

Start
2020-05-01
Primary completion
2024-03-14
Completion
2024-03-14

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 325 mg Oral
Comparator Clopidogrel Small molecule 75 mg Oral