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The Institute for Stroke and Cerebrovascular Disease has implemented trials in the Texas Medical Center since the 1980's when neuroprotective agents for stroke were developed by our team. We have brought forward from our laboratories to clinical trials various new treatment approaches including transcranial ultrasound, adjunctive treatments with t-PA, medications that detoxify hematoma products in brain hemorrhage, and stem cells. We have successfully progressed many of these approaches to phase III clinical trial stages and continuously seek out next-level opportunities in research in our ultimate goals to better the lives of stroke patients and their loved ones.
Click here to view a complete list of Studies by Category(updated August 2022)
勇敢的 - 预防发烧对脑损伤患者的影响多项研究表明,发烧 /温度升高与脑受伤患者的结局不佳有关。但是,没有结论性的研究表明,预防发烧/受控的正常体温与更好的结果有关。将进行这项研究,以评估高级温度控制对预防脑受伤患者发烧的影响。发烧预防组将使用北极太阳温度管理系统,并将与发烧自发发展的标准护理患者进行比较。如果在标准护理组的患者中发烧,则将根据逐步算法对标准发烧护理措施进行治疗,主要由间歇性抗染料药(例如,对乙酰氨基酚)和冷却毯子组成,并在必要时进行高级靶向温度。管理设备。 PI: Huimahn A Choi Coordinator: Glenda L Torres |
中风溶栓的多臂优化(大多数)The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well. PI: Andrew Barreto, MD Coordinator: Jamey D. Franklin |
急性缺血性中风(SEGA)的镇静与一般麻醉The majority of strokes are the result of blood clots in the main vessels that provide blood to the brain. When people suffer from a stroke, these blood clots produce a blockage to the normal flow of blood, which can cause brain tissue to be damaged. This often produces symptoms such as weakness or numbness to one side of the body, changes in vision, or changes in people’s abilities to speak or be understood. PI: Roc Chen, MD |
A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT 2)SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well. The second aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. This will be evaluated by comparing the outcomes in patients with discordant imaging profile and assessing if thrombectomy outcome rates and treatment effect will differ in patients with discordant imaging profiles (favorable CT/unfavorable perfusion imaging and unfavorable CT/favorable perfusion imaging). PI: Amrou Sarraj, MD Coordinator: Faris Shaker |
Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA)The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software. PI: Sunil Sheth, MD Coordinator: Victor S Lopez Rivera |
在符合成像资格的晚期患者中,一项III期,盲目的,随机试验,以评估Tenecteplase的功效和安全性(永恒)这项研究将评估凝块溶解药物Tenecteplase的疗效和安全性,在4.5至24小时时间内到达急诊室的急性缺血性中风(AIS)患者。这可能会将治疗窗口从当前的4.5小时限制到AIS后24小时。 Pi Andrew Barreto,医学博士 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (FASTEST)The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. PI: James Grotta, MD Coordinator: Patti L Bratina |
勇敢的 - 预防发烧对脑损伤患者的影响多项研究表明,发烧 /温度升高与脑受伤患者的结局不佳有关。但是,没有结论性的研究表明,预防发烧/受控的正常体温与更好的结果有关。将进行这项研究,以评估高级温度控制对预防脑受伤患者发烧的影响。发烧预防组将使用北极太阳温度管理系统,并将与发烧自发发展的标准护理患者进行比较。如果在标准护理组的患者中发烧,则将根据逐步算法对标准发烧护理措施进行治疗,主要由间歇性抗染料药(例如,对乙酰氨基酚)和冷却毯子组成,并在必要时进行高级靶向温度。管理设备。 PI: Huimahn A Choi, MD Coordinator: Glenda L Torres |
通过腰导导管(支柱),动脉瘤性蛛网膜下腔出血后脑脊液过滤的前瞻性试验PILLAR-XT研究旨在进一步确认safety and characterize efficacy of Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and does not detract from the established care pathways, or deny enrolled subjects proven therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators who are already trained in the treatment and care of SAH patients and insertion/management of lumbar drains. The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH). PI:Spiros Blackburn,医学博士 |
勇敢的 - 预防发烧对脑损伤患者的影响多项研究表明,发烧 /温度升高与脑受伤患者的结局不佳有关。但是,没有结论性的研究表明,预防发烧/受控的正常体温与更好的结果有关。将进行这项研究,以评估高级温度控制对预防脑受伤患者发烧的影响。发烧预防组将使用北极太阳温度管理系统,并将与发烧自发发展的标准护理患者进行比较。如果在标准护理组的患者中发烧,则将根据逐步算法对标准发烧护理措施进行治疗,主要由间歇性抗染料药(例如,对乙酰氨基酚)和冷却毯子组成,并在必要时进行高级靶向温度。管理设备。 PI: Huimahn A Choi, MD Coordinator: Glenda L Torres |
Haptoglobin基因型在动脉瘤性蛛网膜下腔出血后神经炎症和凝结的作用(NIH K23NS106054)An estimated 2 percent of the population harbors an intracranial aneurysm, and every year more than 30,000 aneurysms will rupture in the U.S. Many who survive go on to have with crippling cognitive and motor deficits despite aggressive surgical and medical intervention. This project seeks to investigate the promising finding that Haptoglobin genotype predicts outcome after aneurysmal subarachnoid hemorrhage, and beyond this, novel mechanisms of inflammation and coagulation to determine future therapeutic targets. PI:Spiros Blackburn,医学博士 |
Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START)主要目的:确定非浮力心房颤动患者缺血性卒中后,用非维生素K口服抗凝剂(NOAC)发起抗凝的最佳时间。 次要目标:
PI: Alicia Zha, MD |
Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START)主要目的:确定非浮力心房颤动患者缺血性卒中后,用非维生素K口服抗凝剂(NOAC)发起抗凝的最佳时间。 次要目标:
PI: Alicia Zha, MD |
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke (ARCADIA)biomarker-driven世外桃源是一个多中心,随机的ized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage. PI: Anjail Sharrief, MPH, MD |
睡眠用于中风管理和恢复试验(睡眠智能)睡眠聪明有前瞻性,随机,open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network. 这项研究的目的是确定急性缺血性中风或高风险TIA不久开始的阻塞性睡眠呼吸暂停(OSA)是否会降低复发性中风,急性冠状动脉综合征和全因死亡率,并减少6个月后该事件和(2)在经历缺血性中风的患者中改善了3个月的3个月的中风结果。 PI: Anjail Sharrief, MPH, MD |
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction (STOP STROKE)这项试验试验的目的是使用跨学科的远程医疗模型[称为中风远程医疗门诊计划(Stop)以降低血压降低的情况下,将冲程后护理血压(BP)进行比较。该干预措施将解决与BP控制中种族差异相关的一般和中风相关因素。我们将评估实施试验的可行性,并将使用试点评估的措施和结果来检查知识差距。 PI: Anjail Sharrief, MPH, MD |
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel (AXIOMATIC)The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention. PI: Anjail Sharrief, MPH, MD Coordinator: Audrey Cohen |
Anticoagulation for Stroke Prevention and Recovery after ICH (ASPIRE)ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet. Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. PI: Andrew Baretto, MD Coordinator: Jamey Franklin |
TRANScranial direct current stimulation for Post-stroke motor Recovery – a phase II sTudy (TRANSPORT-2)This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one. PI:医学博士Gerard Francisco 协调员:Dorothea M Parker |
围产期动脉中风:多个强化婴儿康复的多站点RCT(Iaquire)这是一项III期临床试验,旨在将两种新婴儿康复方案的两种剂量(I -Acquire)与经历过围产期动脉中风(PAS)的婴儿的通常和习惯形式的婴儿康复形式的疗效。 The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hours/day, 5 day/week X 4 weeks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/week X 4 weeks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 months post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS. PI: Nivedita Thakur, MD 协调员:Dorothea M Parker |
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2)MultiStem is an allogeneic, regenerative medicine advanced therapy (stem cells) indicated for treatment of acute ischemic stroke within 36 hours after symptom onset. The objectives of this study are to evaluate the efficacy and safety of MultiStem on functional outcome in participants with ischemic stroke. Further, we want to evaluate the impact of MultiStem on a patient’s quality of life and healthcare and rehabilitation services utilization; and to evaluate the mechanism of action of MultiStem through blood biomarkers, and spleen and brain imaging outcomes in subjects. This is a randomized blinded study. PI Sean Savitz, MD Coordinator: Parker, Dorothea M <Dorothea.M.Parker@uth.tmc.edu> |
NCS-01 (KPharma / IA stem cell)This is an initial Phase1/2 dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 24 hours of stroke onset. This study will be conducted in 2 stages. PI: Sean Savitz, MD |
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