Medication against blood clots to prevent brain infarcts during stent treatment of the carotid artery
- 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.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-005555-27-NL
- Lead Sponsor
- niversity Hospital Basel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 370
- 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280
- 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);
- History of previous symptomatic intracranial haemorrhage at any time (asymptomatic microbleeds do not qualify)
- History of gastrointestinal bleed within the past 6 months;
- Any contraindication to non-contrast MRI, including but not limited to:
-- cardiac pacemaker incompatible with MRI;
-- metal implants incompatible with MRI;
-- claustrophobia;
- Contraindications to ticagrelor, clopidogrel, or aspirin, or to any of their excipients, including known hypersensitivity or allergy;
- Increased risk of bradycardic events (e.g., patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree atrioventricular (AV) block, or history of bradycardia-related syncope;
- Need for medication not permitted during treatment period:
-- Antithrombotic therapy other than Study Medication or permitted concomitant medication including:
--- Antiplatelet therapy (other than Aspirin 75-100 mg daily), e.g.: open-label clopidogrel or ticagrelor; GPIIb/IIIa inhibitors, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol;
--- Therapeutic-dose anticoagulation (other than unfractioned heparin at the start of the CAS procedure), e.g.: phenprocoumon, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins;
--- Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation. If a patient requires intravenous or intra-arterial thrombolytic therapy during the treatment period, the Study Medication must be discontinued for at least 24 hours;
-- Strong cytochrome P450 3A (CYP3A) inhibitors leading to substantial increases in ticagrelor plasma levels: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir; or consumption of more t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method