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)

niversity Hospital Basel0 sites370 target enrollmentApril 13, 2017

ConditionsCarotid artery stenting (CAS) is treatment for atherosclerotic carotid stenosis. The main adverse events are thromboembolic brain infarcts during the procedure. Ticagrelor, a novel reversible inhibitor of the platelet adenosine diphosphate receptor P2Y12, was superior to clopidogrel as add-on to aspirin in preventing stent thrombosis and clinical adverse events during stenting of the coronary artery. Therefore, ticagrelor may be superior to clopidogrel in preventing brain infarcts during CAS.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

DrugsTicagrelor (BRILIQUE®) AZD6140 Clopidogrel Zentiva

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Carotid artery stenting (CAS) is treatment for atherosclerotic carotid stenosis. The main adverse events are thromboembolic brain infarcts during the procedure. Ticagrelor, a novel reversible inhibitor of the platelet adenosine diphosphate receptor P2Y12, was superior to clopidogrel as add-on to aspirin in preventing stent thrombosis and clinical adverse events during stenting of the coronary artery. Therefore, ticagrelor may be superior to clopidogrel in preventing brain infarcts during CAS.
Sponsor: niversity Hospital Basel
Enrollment: 370
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 13, 2017

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospital Basel

Eligibility Criteria

Inclusion Criteria

•\- Written informed consent as documented by signature from the patient;
•\- Men or women \=40 years of age;
•\- Moderate (50\-69% narrowing) or severe (70\-99% narrowing) stenosis of the extracranial internal carotid artery caused by atherosclerosis;
•\- Symptomatic carotid stenosis (any transient or permanent symptoms caused by focal ischaemia in the vascular territory supplied by the carotid artery in the past 180 days, including ischaemic stroke, transient ischaemic attack (TIA), amaurosis fugax or ischaemic retinal infarct), as long as the patient is clinically stable and independent (modified Rankin Scale \=2\) at the time of randomisation; or asymptomatic carotid stenosis (no ischaemic symptoms in the past 180 days);
•\- Stenosis amenable for treatment by carotid artery stenting (CAS) according to routine clinical work\-up (degree of stenosis and suitability of vascular anatomy for CAS must be demonstrated either by consistent findings on two of the following non\-invasive imaging modalities: duplex ultrasound, magnetic resonance angiography, or computer tomography angiography; or by intra\-arterial digital subtraction angiography);
•\- CAS scheduled to take place within 1\-3 days of randomisation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 90

Exclusion Criteria

•\- Inability or unwillingness of the patient to understand and/or comply with study procedures and/or follow\-up, e.g. due to language problems, psychological disorders, dementia, etc.;
•\- Women who are pregnant or breast feeding, or who intend to become pregnant during the course of the study. Women of childbearing age must take a pregnancy test to be eligible for the study;
•\- Lack of safe contraception, defined as: Female Participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. Female Participants who are surgically sterilised / hysterectomised or post\-menopausal for longer than 2 years are not considered as being of child bearing potential;
•\- Acute ischaemic stroke with symptom onset in the previous 24 hours before randomisation;
•\- Fresh thrombus in the relevant carotid artery;
•\- Patient clinically unstable at the time of randomisation (includes worsening in NIH Stroke Scale of \>2 points over the previous 24 hours);
•\- Patient dependent on others in functions of daily living at the time of randomisation (score on the modified Rankin Scale \>2\);
•\- Patients with known bleeding diathesis or coagulation disorder (e.g., thrombotic\-thrombocytopenic purpura);
•\- Any active pathological bleed;
•\- Severe thrombocytopenia (platelet count \<50’000/uL);