Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 358
- 试验地点
- 18
- 主要终点
- Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
研究概览
简要总结
The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.
详细描述
This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 85 years
- •Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery [C5-C7], middle cerebral artery [M1], vertebral artery [V4], or basilar artery) on CTA (According to WASID method)
- •The diameter of the target vessel between 2.0mm - 4.5mm
- •The stenosis lesion length ≤ 14 mm
- •Baseline modified Rankin Scale (mRS) score ≤ 3
- •Patient understands the purpose and requirements of the study, and has provided informed consent
排除标准
- •Ischemic stroke occurred within 7 days before enrolment
- •Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
- •Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
- •Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
- •Stroke caused by perforating artery occlusion
- •CT angiographic evidence of severe calcification at target lesion
- •Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
- •Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
- •History of stenting of an intracranial artery
- •Presence of any unequivocal cardiac source of embolism
- •Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
- •Cannot tolerate dual antiplatelet therapy
- •Contraindications to heparin, rapamycin, contrast and local or general anesthesia
- •Hemoglobin<100g/L, platelet count <100×109/L
- •Severe hepatic and renal dysfunction
- •INR>1.5 or there are uncorrectable factors leading to bleeding
- •Major surgery within the past 30 days or planned within 90 days
- •Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
- •Life expectancy <1 year
- •Pregnant or lactating women
- •Cannot complete the follow-up due to cognitive, emotional or mental illness
- •Other situations that are not suitable for enrolment according to the judgement of the investigator
- •Enrolment in another study that would conflict with the current study
研究组 & 干预措施
Drug-eluting stent implantation with aggressive medical treatment group
DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
干预措施: Drug Eluting Stent implantation (Device)
Drug-eluting stent implantation with aggressive medical treatment group
DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
干预措施: Aggressive medical treatment (Drug)
Drug-eluting stent implantation with aggressive medical treatment group
DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
干预措施: Risk factor management (Behavioral)
Standard medical treatment group
Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
干预措施: Standard medical treatment (Drug)
Standard medical treatment group
Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
干预措施: Risk factor management (Behavioral)
结局指标
主要结局
Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
时间窗: 12 months after enrollment
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure.
Severe or moderate bleeding (GUSTO score)
时间窗: 12 months after enrollment
Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding: Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding
次要结局
- Disabling stroke within 1 year(12 months after enrollment)
- Residual stenosis after the procedure in DES group(At the end of the procedure)
- In-stent restenosis (ISR) rate in DES group within 12 months(12 months after enrollment)
- Any stroke, death or myocardial infarction within 1 year(12 months after enrollment)
- Major non-stroke hemorrhage within 1 year(12 months after enrollment)
- Modified Rankin Scale score at 1 year(12 months after enrollment)
- Death within 1 year(12 months after enrollment)
- Symptomatic intracranial hemorrhage within 1 year(12 months after enrollment)