EUCTR2015-004505-16-BE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 3,154 人开始时间: 2019年3月6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
- 3,154
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 the screening assessment and 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. Patient has had either;-
- •An ischaemic stroke without major disability (modified Rankin score 3 or
- •less)(Clarification - retinal infarction due to retinal artery occlusion is
- •A high risk TIA*
- •A brain CT or MRI has excluded primary intracranial haemorrhage
- •The stroke/TIA has occurred more than 72 hours before randomisation
- •AND no more than 28 days prior to randomisation
- •* High-risk TIA is defined as transient focal neurological symptoms of
- •presumed vascular cause with, in addition, one or more of the following
- •(a) ABCD2 score 4 or more, with motor or speech symptoms (dysarthria
- •or dysphasia)
- •(b) DWI hyperintensity on acute MRI
- •(c) Stenosis (lumen narrowing of 50% or greater on ultrasound, MRA,
- •CTA, or invasive angiography) of the internal cartoid, 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 treating physician.
- •5. eGFR greater than or equal to 50 ml/min.
- •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 1125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2029
排除标准
- •1.Stroke/TIA, probably caused by identified atrial fibrillation
- •(permanent or paroxysmal), in the opinion of the treating physician.
- •2.Stroke/TIA probably caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart valve, low ejection
- •fraction <30%),
- •3.Stroke/TIA caused by dissection, endocarditis, paradoxical
- •embolism, drug use, venous thrombosis, carotid or cardiac surgery,
- •hypercoagulability states, migraine, or inherited cerebrovascular
- •4.History of myopathy or myalgias with raised creatine kinase (CK) on
- •statin therapy.
- •5.Blood dyscrasia (haemoglobin<10g/dL,platelet count <150 x109/L,
- •white cell count <4 x109/L)
- •6.Impaired hepatic function (transaminases ALT and/or AST greater
- •than twice upper limit of normal)
- •7.Concurrent treatment with colchicine contraindicated drugs:-
- •CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other
- •macrolide antibiotics, ketoconazole, itraconazole,
- •voriconazole,tolbutamide, ritonavir, atazanavir, indinavir, other HIV
- •protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram)
- •or P-gp inhibitors (cyclosporine) at randomisation.
- •8.Symptomatic peripheral neuropathy and pre-existing progressive
- •neuromuscular disease
- •9.Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic
- •10.Dementia, sufficient to impair independence in basic activities of
- •daily living.
- •11.Active malignancy, known hepatitis B or C, or HIV infection.
- •12.Impaired swallow preventing oral administration of Colchicine
- •13.History of poor medication compliance.
- •14.Unlikely to comply with study procedures due to severe or fatalcomorbid illness or other factor (eg. inability to travel for follow up
- •visits), in opinion of randomising physician.
- •15.Women of childbearing potential (WCBP), or pregnant or are
- •breastfeeding, are not eligible to participate in this study. (Clarification:
- •A woman of childbearing potential is a woman who:
- •- has not had surgery to remove the uterus and ovaries
- •- has had menstrual periods at any time in the preceding 24
- •consecutive months
- •- Menstrual periods interrupted due to cancer chemotherapy
- •treatment are considered WCBP as this may still allow conception.)
- •Pregnancy is considered highly unlikely during the trial because
- •women of childbearing potential are excluded. However, in the unlikely
- •event that a woman in the trial becomes pregnant, pregnancy
- •information will be collected.
- •16.Patient concurrently participating in another clinical trial with an
- •investigational drug or device, or use of investigational drug within 30 or
- •5 half-lives before the Screening visit (whichever is longer).
- •17.Known allergy or sensitivity to colchicine.
- •18.Requirement for colchicine therapy for treatment of acute gout,
- •gout prevention, or other rheumatological disorder
- •19.Requirement for chronic daily immunosuppressants oral steroids, or
- •non-steroidal anti-inflammatory drugs (NSAIDs)
研究者
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