NCT02677545

Ticagrelor Versus Clopidogrel in Carotid Artery Stenting

Prevention of Cerebral Ischaemia in Stent Treatment for Carotid Artery Stenosis - A Randomised Multi-centre Phase II Trial Comparing Ticagrelor Versus Clopidogrel With Outcome Assessment on MRI (PRECISE-MRI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Patients with symptomatic or asymptomatic carotid stenosis in whom carotid artery stenting is planned are randomised between antiplatelet therapy with ticagrelor plus aspirin or clopidogrel plus aspirin and examined with brain MRI before and after stent treatment. The proportion of patients with new ischaemic lesions on MRI after treatment is compared between the two groups.

Detailed description

Carotid artery stenting (CAS) is an emerging treatment for atherosclerotic carotid stenosis. The main adverse event is embolic stroke during the procedure. Current medical management to prevent peri-procedural embolisation consists of dual antiplatelet therapy with clopidogrel and aspirin. Ticagrelor, a novel reversible inhibitor of the platelet adenosine diphosphate receptor P2Y12, was superior to clopidogrel, as add-on therapy to aspirin, in preventing stent thrombosis, cardiovascular outcome events, and death in patients undergoing coronary artery stenting, without causing an increase in major bleeding events. This study aims to test the hypothesis that ticagrelor is superior to clopidogrel as add-on to aspirin in preventing cerebral embolism during the CAS procedure.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DRUG	Ticagrelor
DRUG	Clopidogrel
DRUG	Aspirin

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2016-02-09
• Last updated: 2022-06-28

Locations

15 sites across 6 countries: Belgium, Germany, Italy, Netherlands, Switzerland, United Kingdom