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: 7858317
• 负责人: MARC IVOR CHIMOWITZ
• 金额: $ 420万
• 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 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7858317
• 关键词: SAMMPRIS; Stenting; vs.; Aggressive; Medical

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：主要颅内动脉的动脉粥样硬化狭窄是中风的重要原因，在美国，每年约50,000笔中风，在1年内为7.5亿美元，在这些患者的寿险中为45亿美元。我们的研究组先前进行的NIH资助的临床试验（WASID）表明，阿司匹林比华法林更有效，更安全，可预防颅内狭窄患者中风，并且颅内狭窄70％-99％的患者的中风风险很高。尽管抗血栓疗法和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，例如对血管危险因素进行密集管理和颅内支架。在本应用中，我们提出了一项随机临床试验来解决以下主要目的：确定颅内支架（使用Wingspan自扩张硝基支架）和强化医疗疗法是否优于仅仅是强化医疗疗法，以防止主要终点（任何任何终结点）在有症状的颅内动脉征收或中风后30天内的30天内的中风或死亡超过30天），在高危患者中的平均随访中，有症状的主要颅内动脉症状。研究的两个臂中的强化药物治疗将包括阿司匹林325 mg / day，用于整个随访，氯吡格雷每天75mg每天在入学后90天，而积极的危险因素管理主要针对血压<130 /80 mm Hg，较低密度胆固醇<70 mg / dl。主要假设是，与仅强烈的医疗疗法相比，颅内支架与强化药物疗法相结合，在两年的高危患者中，在两年的平均随访中，主要终点的风险将降低35％。颅内动脉。基于logrank测试的支架降低35％所需的样本量，其alpha的支架速率为0.05，80％功率，并调整了2％的损失以进行随访和5％的交叉。从医疗到支架臂是每组382名患者。患者将每4个月通过研究神经科医生对患者进行评估，以确定终点的发生以及将管理所有研究患者血管风险因素的研究内科医生。可以预期，这项研究的结果是第一个二级预防中风试验在研究设计中纳入多个危险因素的密集管理，并且也是第一阶段III颅内支架置于试验，它将为此提供更有效的疗法常见的脑血管疾病与预后不良有关。