SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing

SAMMPRIS（支架置入术与积极的医疗管理预防

• 批准号: 7696264
• 负责人: MARC IVOR CHIMOWITZ
• 金额: $ 397.83万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7696264
• 关键词: Accounting; Address; Alternative Therapies; Arteries; Asians; Aspirin; Blood Pressure; Blood Vessels; Bypass; Cerebrovascular Disorders; Cessation of life; Cholesterol; Clinical; Clinical Trials; Developed Countries; Developing Countries; Disease; Economics; End Point; Enrollment; Female; Funding; Gender; Hispanics; Internist; Ischemic Stroke; Lead; Life; Medical; Myocardial Infarction; Neurologist; Patients; Phase; Population; Process; Randomized; Randomized Clinical Trials; Rate; Recurrence; Research Design; Research Personnel; Risk; Risk Factors; Safety; Sample Size; Secondary Prevention; Stenosis; Stents; Stroke; Stroke prevention; Subgroup; Testing; Therapeutic; Time; United States National Institutes of Health; Upper arm; Warfarin; base; basilar artery; blood pressure regulation; clopidogrel; cost; day; density; follow-up; intracranial artery; middle cerebral artery; nitinol; outcome forecast; prevent; racial and ethnic; spine bone structure; trial comparing; vertebral artery

Atherosclerotic stenosis of the major intracranial arteries is an important cause of stroke, accounting for approximately 50,000 strokes per year in the USA at a cost of $750,000,000 in year 1 and $4.5 billion over the life time of these patients. A previous NIH funded clinical trial (WASID) performed by our study group showed that aspirin was as effective and safer than warfarin for preventing stroke in patients with intracranial stenosis, and that patients with 70%-99% intracranial stenosis had a high risk of stroke despite antithrombotic therapy and usual management of vascular risk factors. The high risk of stroke in these patients suggests the need for alternative therapies such as intensive management of vascular risk factors and intracranial stenting. In this application we are proposing a randomized clinical trial to address the following primary aim: To determine whether intracranial stenting (using the Wingspan self-expanding nitinol stent) and intensive medical therapy is superior to intensive medical therapy alone for preventing the primary endpoint (any stroke or death within 30 days after enrollment or stroke in the territory of the symptomatic intracranial artery beyond 30 days) during a mean follow-up of two years in high-risk patients with symptomatic stenosis of a major intracranial artery. Intensive medical therapy in both arms of the study will consist of aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment, and aggressive risk factor management primarily targeting blood pressure < 130 / 80 mm Hg and low density cholesterol < 70 mg / dl. The Primary Hypothesis is that compared with intensive medical therapy alone, intracranial stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients with symptomatic stenosis of a major intracranial artery. The sample size required to detect a 35% reduction in the rate of the primary endpoint from stenting based on the logrank test with an alpha of 0.05, 80% power, and adjusting for a 2% loss to follow-up and a 5% crossover from the medical to the stenting arm is 382 patients per group. Patients will be evaluated by study neurologists every 4 months to determine the occurrence of endpoints and by study internists who will manage the vascular risk factors of all study patients. It is expected that the results of this study, which is the first secondary prevention stroke trial to incorporate intensive management of multiple risk factors in the study design, and is also the first Phase III intracranial stenting trial, will lead to more effective therapies for this common cerebrovascular disorder that is associated with a poor prognosis.

颅内主要动脉粥样硬化性狭窄是脑卒中的重要原因，占 在美国，每年约50，000次中风，第1年的成本为750，000，000美元， 这些患者的生命周期。我们的研究小组先前进行的NIH资助的临床试验（WASID）显示， 阿司匹林在预防颅内狭窄患者卒中方面与华法林一样有效和安全， 颅内动脉狭窄70%-99%的患者，尽管进行了抗血栓治疗， 以及血管危险因素的常规管理。这些患者中风的高风险表明需要 替代疗法，如血管危险因素的强化管理和颅内支架植入术。在这 我们提出了一项随机临床试验，以解决以下主要目标： 颅内支架植入术（使用Wingspan自膨式镍钛合金支架）和强化药物治疗是否 在预防主要终点（30年内的任何卒中或死亡）方面优于单独的强化药物治疗上级 入组后30天或症状性颅内动脉区域卒中超过30天）， 主要颅内动脉有症状性狭窄的高危患者平均随访2年。 研究两组的强化药物治疗将包括阿司匹林325 mg /天，用于整个随访， 氯吡格雷75 mg/天，入组后90天，积极的风险因素管理主要是 目标血压< 130 / 80 mm Hg和低密度胆固醇< 70 mg / dl。主要假设 与单纯强化药物治疗相比，颅内支架植入术联合强化药物治疗， 在高风险患者中，治疗将在平均随访2年的时间内将主要终点的风险降低35%。 颅内主要动脉有症状性狭窄的患者。检测35%所需的样本量 基于对数秩检验（α = 0.05，80%），支架植入术的主要终点发生率降低 把握度，并调整2%的失访和5%的医疗组与支架组交叉， 患者每组。研究神经学家将每4个月对患者进行一次评估，以确定 终点的发生率以及将管理所有研究患者血管风险因素的研究内科医生。 预计这项研究的结果，这是第一个二级预防中风试验， 在研究设计中强化管理多种风险因素，也是第一个III期颅内 支架试验，将导致更有效的治疗这种常见的脑血管疾病， 预后很差