International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial Multicenter Study
A double-blind, placebo-controlled, randomized, multicenter study to investigate CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES Study).
Rationale Traditional Chinese Medications(TCM) have been reported to have beneficial effects in stroke patients, but were not rigorously evaluated by GCP standards. Aim This study tests the hypothesis that Neuroaid, a TCM widely used in China post-stroke, is superior to placebo in reducing neurological deficit and improving functional outcome in patients with acute cerebral infarction of an intermediate severity. Design This is a multicenter, randomised, double-blind, placebo-controlled study of Neuroaid in ischemic stroke patients with National Institute of Health Stroke Scale(NIHSS) 6-14 treated within 48 h of stroke onset. Neuroaid or placebo is taken (4 capsules) 3 times daily for 3 months. Treatments are assigned using block randomization, stratified for centers, via a central web-randomization system. With a power of 90% and two-sided test of 5% type I error, a sample size is 874. Allowing for a drop-out rate of up to 20%, 1100 individuals should be enrolled in this study. Study Outcomes The primary efficacy endpoint is the modified Rankin Scale(mRS) grades at 3 months. Secondary efficacy endpoints are the NIHSS score at 3 months; difference of NIHSS scores between baseline and 10 days, and between baseline and 3 months; difference of NIHSS sub-scores between baseline and 10 days, and between baseline and 3 months; mRS at 10 days, 1 month, and 3 months; Barthel index at 3 months; Mini Mental State Examination at 10 days and 3 months. Safety outcomes include complete blood count, renal and liver panels, and electrocardiogram. ⋯ ClinicalTrials.gov identifier: NCT00554723.
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Randomized Controlled Trial Multicenter Study
Minimally invasive craniopuncture therapy vs. conservative treatment for spontaneous intracerebral hemorrhage: results from a randomized clinical trial in China.
To evaluate the effects of minimally invasive craniopuncture therapy compared with conservative treatment in treating intracerebral hemorrhage (25-40 ml) in the basal ganglion. ⋯ This minimally invasive craniopuncture technique can improve the independent survival of patients with small basal ganglion hemorrhage. It is a safe and practical technique in treating cerebral hemorrhage.
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Randomized Controlled Trial Multicenter Study
Magnesium in aneurysmal subarachnoid hemorrhage (MASH II) phase III clinical trial MASH-II study group.
Delayed cerebral ischemia (DCI) is an important cause of poor outcome after aneurysmal subarachnoid hemorrhage (SAH). Magnesium is a neuroprotective agent that acts as an NMDA-receptor antagonist and a calcium channel blocker. In a phase II randomized clinical trial of 283 patients, magnesium treatment reduced the risk of DCI by 34% and of poor outcome by 23%. ⋯ Primary outcome will be poor clinical outcome as measured by the modified Rankin scale at 3 months.
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Randomized Controlled Trial Multicenter Study Comparative Study
Antiplatelet therapy vs. anticoagulation in cervical artery dissection: rationale and design of the Cervical Artery Dissection in Stroke Study (CADISS).
Cervical artery dissection is an important cause of stroke in the young. It can present with local symptoms or stroke/transient ischaemic attacks. Following presentation there is a risk of stroke, particularly in the first month following presentation. The mechanism of stroke is believed to be thromboembolic in the majority of cases. Many clinicians anticoagulate patients with cervical dissection for 3-6 months. This is not evidence based and is supported by a paucity of data and no data from randomised control trials. ⋯ The primary end-point is ipsilateral stroke or death within 3 months from randomisation. Secondary end-points include any TIA or stroke, major bleeding and presence of residual stenosis at 3 months (>50%). All neuroimaging and serious adverse events will be adjudicated blinded to treatment. An initial feasibility phase of 250 subjects will allow us to determine whether *there are sufficient clinical end-points to provide the power to determine a treatment effect and *adequate numbers of patients can be recruited. The feasibility phase will be continued into a fully powered definitive treatment trial. Initial power calculations based on limited natural history data suggest a sample size of approximately 3000. Sample size calculations will be refined once the frequency of outcome events during the feasibility phase is known.
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Randomized Controlled Trial Multicenter Study
Promoting Acute Thrombolysis for Ischaemic Stroke (PRACTISE).
Thrombolysis with intravenous rtPA is an effective treatment for patients with ischaemic stroke if given within 3 h from onset. Generally, more than 20% of stroke patients arrive in time to be treated with thrombolysis. Nevertheless, in most hospitals, only 1-8% of all stroke patients are actually treated. Interorganisational, intraorganisational, medical and psychological barriers are hampering broad implementation of thrombolysis for acute ischaemic stroke. ⋯ This study will provide important information on the effectiveness and cost-effectiveness of actively implementing an established treatment for acute ischaemic stroke. The multifaceted aspect of the intervention will make it difficult to attribute a difference in the primary outcome measure to a specific aspect of the intervention. However, careful monitoring of intermediate parameters as well as monitoring of accomplished SMART tasks can be expected to provide useful insights into the nature and role of factors associated with implementation of thrombolysis for acute ischaemic stroke, and of effective acute interventions in general.