SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing
SAMMPRIS(支架置入术与积极的医疗管理预防
基本信息
- 批准号:7696264
- 负责人:
- 金额:$ 397.83万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AccountingAddressAlternative TherapiesArteriesAsiansAspirinBlood PressureBlood VesselsBypassCerebrovascular DisordersCessation of lifeCholesterolClinicalClinical TrialsDeveloped CountriesDeveloping CountriesDiseaseEconomicsEnd PointEnrollmentFemaleFundingGenderHispanicsInternistIschemic StrokeLeadLifeMedicalMyocardial InfarctionNeurologistPatientsPhasePopulationProcessRandomizedRandomized Clinical TrialsRateRecurrenceResearch DesignResearch PersonnelRiskRisk FactorsSafetySample SizeSecondary PreventionStenosisStentsStrokeStroke preventionSubgroupTestingTherapeuticTimeUnited States National Institutes of HealthUpper armWarfarinbasebasilar arteryblood pressure regulationclopidogrelcostdaydensityfollow-upintracranial arterymiddle cerebral arterynitinoloutcome forecastpreventracial and ethnicspine bone structuretrial comparingvertebral artery
项目摘要
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
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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MARC IVOR CHIMOWITZ其他文献
MARC IVOR CHIMOWITZ的其他文献
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{{ truncateString('MARC IVOR CHIMOWITZ', 18)}}的其他基金
Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
抗凝与抗血小板治疗颅内血管粥样硬化的比较
- 批准号:
10211763 - 财政年份:2021
- 资助金额:
$ 397.83万 - 项目类别:
Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
抗凝与抗血小板治疗颅内血管粥样硬化的比较
- 批准号:
10478009 - 财政年份:2021
- 资助金额:
$ 397.83万 - 项目类别:
South Carolina Clinical & Translational Research Institute (SCTR)
南卡罗来纳州临床
- 批准号:
9251334 - 财政年份:2015
- 资助金额:
$ 397.83万 - 项目类别:
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 - 财政年份:2008
- 资助金额:
$ 397.83万 - 项目类别:
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:
8064697 - 财政年份:2008
- 资助金额:
$ 397.83万 - 项目类别:
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:
7617204 - 财政年份:2008
- 资助金额:
$ 397.83万 - 项目类别:
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:
7382822 - 财政年份:2008
- 资助金额:
$ 397.83万 - 项目类别:
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