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Ischemic Stroke clinical trials

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NCT ID: NCT01763320 Completed - Ischemic Stroke Clinical Trials

China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis

CASSISS
Start date: March 5, 2014
Phase: Phase 3
Study type: Interventional

Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment, however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience, neither regarding natural history, nor treatment complications rate. As ICAS is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective randomized multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. The China Angioplasty & Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial, is an ongoing, government-funded, prospective, multicenter randomized trial. It recruits patients with recent TIA or stroke caused by 70-99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume center with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days The CASSISS trial will be conducted in 8 sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 subjects (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by Dec, 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high volume centers.

NCT ID: NCT01762163 Completed - Ischemic Stroke Clinical Trials

Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

Start date: October 2013
Phase: Phase 4
Study type: Interventional

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.

NCT ID: NCT01758536 Recruiting - Ischemic Stroke Clinical Trials

Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke

HTZZP-INF
Start date: December 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.

NCT ID: NCT01757795 Completed - Ischemic Stroke Clinical Trials

Safety, Tolerability and Pharmacokinetics of SP-8203

Start date: December 23, 2013
Phase: Phase 1
Study type: Interventional

Phase I study in health volunteers to assess the safety, tolerability and pharmacokinetics of escalating single doses and multiple doses of SP-8203

NCT ID: NCT01728649 Withdrawn - Ischemic Stroke Clinical Trials

Reperfusion With Cooling in Cerebral Acute Ischemia II

ReCCLAIM II
Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).This will be achieved by comparing patients that have undergone hypothermia to those that have not.

NCT ID: NCT01706094 Completed - Ischemic Stroke Clinical Trials

Head Position in Stroke Trial

HeadPoST-Pilot
Start date: January 2013
Phase: N/A
Study type: Interventional

A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute ischemic stroke could be to place the patient in a 'lying flat' rather than upright head position. Given uncertainty over the balance of potential modest benefits and risks, and variability regarding the ideal head position policy for patients with acute ischemic stroke around the world, reliable randomized evidence is required to standardize clinical practice. The main objectives of this pilot phase clinical trial are to determine the feasibility, safety and potential efficacy of a large-scale cluster randomized clinical trial to assess whether a simple nursing care policy - 'lying flat head position' - provides beneficial effects as compared to the standard upright head position in patients with acute ischemic stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity in the flat down compared to the upright head position, as assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days.

NCT ID: NCT01703663 Completed - Clinical trials for Obstructive Sleep Apnea

Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Start date: November 2012
Phase: Phase 2
Study type: Interventional

Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke. Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night. Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.

NCT ID: NCT01700166 Withdrawn - Clinical trials for Arterial Ischemic Stroke (AIS) in Children

Umbilical Cord Blood in the Treatment of Stroke in Children.

Pedi Stroke
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The specific aims of this study are: 1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS). 2. To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.

NCT ID: NCT01683591 Completed - Ischemic Stroke Clinical Trials

Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

DASH
Start date: April 2009
Phase: N/A
Study type: Observational

Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using High-resolution impedance manometry (DASH). The hypothesis tested in this study is that high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients.

NCT ID: NCT01678534 Completed - Ischemic Stroke Clinical Trials

Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial

AMASCIS-01
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients