EUCTR2015-005555-27-BE进行中（未招募）1 期
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 个研究点目标入组 370 人开始时间: 2019年6月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Written informed consent as documented by signature from the patient;
- •- Men or women =40 years of age;
- •- Moderate (50-69% narrowing of the artery according to the measuring method used in the NASCET trial) or severe (70-99%) 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, TIA, amaurosis fugax or ischaemic retinal infarct), as long as the patient is clinically stable and able to walk unassisted (mRS =3) at the time of randomisation; or asymptomatic carotid stenosis (no ischaemic symptoms in the past 180 days);
- •- Stenosis amenable for treatment by CAS according to routine clinical work-up (degree of stenosis and suitability of vascular anatomy for CAS must be documented on vascular imaging within 90 days before the screening visit);
- •- 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
排除标准
- •- 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 blood 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 unable to walk unassisted at the time of randomisation (score on the modified Rankin Scale >3);
- •- 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 di
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