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)

Phase 2

Completed

• Conditions: carotid narrowing; atherosclerotic carotid artey stenosis; 10007963

• Registration Number: NL-OMON47608
• Lead Sponsor: niversitätsspital Basel (USB), Departement of Neurology and Stroke Center

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

Patients with symptomatic or asymptomatic atherosclerotic carotid stenosis
(*50% narrowing of the lumen) in whom revascularisation of the stenosis by CAS
is planned routinely are eligible to participate in the study.

Exclusion Criteria

Contraindication against use of ASA (acetylsalicylic acid), clopidogrel, or
ticagrelor; anticoagulation; thrombolysis within the previous 24 hours; unable
to walk unassisted (modified Rankin Scale >3); clinically unstable; acute
coronary syndrome; need for any cardio-vascular surgery or intervention, or
need for any other invasive procedure requiring halting of Study Medication
during the Study, other than the index CAS procedure for which the patient was
randomised; bradycardia; dyspnoea; contraindications against MRI
(claustrophobia, metal implants, cardiac pacemaker); or participation in
another intervention trial. No so-ccalled vulnerable patients will be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome is the presence of at least one new ischaemic<br /><br>brain lesion on the second MRI scan done 1-3 days after CAS or on the third MRI<br /><br>scan done 28-32 days after CAS, which had not been present on the first MRI<br /><br>scan done 1-3 days before CAS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy outcomes are: (1) the total number of new ischaemic brain<br /><br>lesions on MRI after CAS; and (2) the total volume of new ischaemic brain<br /><br>lesions on MRI after CAS, defined as the sum of all volumes of separate DWI<br /><br>lesions.</p><br>