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)

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) - PRECISE-MRI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47608

Enrollment

Registered

2019-06-25

Start date

2017-12-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carotid narrowing

Interventions

Intervention: Ticagrelor 90 mg tablets will be used. Participants will receive a loading dose of 180 mg followed by a maintenance dose of 90 mg twice daily. Control intervention: Clopidogrel 75 mg t

carotid artery

carotid artery stenting

carotid stenosis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary efficacy outcomes are: (1) the total number of new ischaemic brain lesions on MRI after CAS; and (2) the total volume of new ischaemic brain lesions on MRI after CAS, defined as the sum of all volumes of separate DWI lesions.	—

Countries

Germany, Italy, Netherlands, Switzerland, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)