EUCTR2015-004505-16-ES进行中（未招募）1 期
CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicinefor secondary prevention after stroke
niversity College Dublin0 个研究点目标入组 2,623 人开始时间: 2016年7月15日最近更新:
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
- 2,623
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
- 性别
- All
入选标准
- •To be eligible for inclusion, each subject must meet each of the following criteria at Screening Assessment and must continue to fulfil these criteria at enrolment into the trial (Baseline Visit).
- •1. Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to all trial-related procedures.
- •2. Age 40 years or greater.
- •3. Either,
- •ischaemic stroke without major disability (modified Rankin score 3 or less)
- •or high-risk TIA
- •within 72 hours-28 days of randomisation
- •Primary intracranial haemorrhage excluded by brain CT or MRI.
- •High-risk TIA is defined as transient focal neurological symptoms of presumed vascular cause with, in addition, one or more of the following criteria:
- •(a) ABCD2 score 4 or more, with motor or speech symptoms (dysarthria or dysphasia)
- •(b) Diffusion-Weighted Imaging (DWI) hyperintensity on acute MRI
- •(c) Stenosis (lumen narrowing of 50% or greater on ultrasound, magnetic resonance angiography (MRA), computed tomographic angiography (CTA), or invasive angiography) of the internal carotid, vertebral, middle cerebral, anterior cerebral, or basilar artery in the arterial territory consistent with symptoms
- •4. Qualifying stroke/TIA probably caused by large artery stenosis, small artery occlusion (lacunar stroke), or cryptogenic embolism, with cardiac embolism or other defined stroke mechanism deemed unlikely, in the opinion of the Investigator.
- •5. Creatinine clearance >50 ml/min, by MDRD or CKD-EPI formula.
- •6. In the opinion of the treating physician, patient is medically-stable, capable of participating in a randomised trial, and willing to attend follow-up.
- •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 875
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1748
排除标准
- •Subjects are excluded from the study if any of the following criteria are met:
- •1. Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation (permanent or paroxysmal), in the opinion of the treating physician.
- •2. Cardio-embolic stroke/TIA probably caused by other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction <30%), in the opinion of the treating physician.
- •3. Stroke/TIA caused by dissection, endocarditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours after carotid or cardiac surgery, hypercoagulability states, migraine, or inherited cerebrovascular disorders (eg. Fabry’s disease, CADASIL), in the opinion of the treating physician.
- •4. History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.
- •5. Blood dyscrasia, defined as anaemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <150 x109/L) or leucopenia (white cell count <4 109/L) within 14 days of randomisation.
- •6. Impaired renal function (creatinine clearance =50mL/min or dialysis) or hepatic function (aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) greater than twice upper limit of normal).
- •7. Use of a moderate or strong CYP3A4 inhibitor or a P-gp inhibitor at randomisation (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, voriconazole, itraconizole, HIV protease inhibitors [ritonavir, indinavir, atazanavir], verapamil, diltiazem, quinidine, disulfiram, cyclosporine, regular grapefruit juice, cimetidine, tolbutamide).
- •8. Symptomatic peripheral neuropathy.
- •9. Dementia, sufficient to impair independence in basic activities of daily living.
- •10. Active malignancy, known hepatitis B or C, or HIV infection prior to qualifying stroke/TIA.
- •11. Impaired swallow preventing oral administration of study medication.
- •12. History of poor medication compliance considered significant in opinion of randomising physician.
- •13. Unlikely to comply with study procedures and follow-up visits due to severe or fatal comorbid illness or other factor (e.g. inability to travel for follow up visits), in opinion of randomising physician.
- •14. Pregnancy, breast-feeding, or pre-menopausal women, defined as one or more menstrual periods within the last 12 months
- •15. Patient concurrently participating in another clinical trial with an investigational drug or device.
- •16. Known allergy or sensitivity to colchicine.
- •17. Requirement for colchicine therapy for treatment of gout or other rheumatological disorder.
研究者
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