International journal of stroke : official journal of the International Stroke Society
-
Letter Randomized Controlled Trial Multicenter Study
Update protocol Preventive Antibiotics in Stroke Study (PASS).
-
Existing methods of primary stroke prevention are not sufficiently effective. Based on the recently developed Stroke Riskometer app, a new 'mass-elevated risk stroke/cardiovascular disease prevention' approach as an addition to the currently adopted absolute risk stroke/cardiovascular disease prevention approach is being advocated. We believe this approach is far more appealing to the individuals concerned and could be as efficient as the conventional population-based approach because it allows identification and engagement in prevention of all individuals who are at an increased (even slightly increased) risk of stroke and cardiovascular disease. ⋯ Second, it employs self-management strategies to engage the person concerned in stroke/cardiovascular disease prevention, which is tailored to the person's individual risk profile. Preventative strategies similar to the Stroke Riskometer could be developed for other non-communicable disorders for which reliable predictive models and preventative recommendations exist. This would help reduce the burden of non-communicable disorders worldwide.
-
Randomized Controlled Trial Multicenter Study Comparative Study
SOLITAIRE™ with the intention for thrombectomy (SWIFT) trial: design of a randomized, controlled, multicenter study comparing the SOLITAIRE™ Flow Restoration device and the MERCI Retriever in acute ischaemic stroke.
Self-expanding stent retrievers are a promising new device class designed for rapid flow restoration in acute cerebral ischaemia. The SOLITAIRE™ Flow Restoration device (SOLITAIRE) has shown high rates of recanalization in preclinical models and in uncontrolled clinical series. ⋯ The primary efficacy end-point is successful recanalization with the assigned study device (no use of rescue therapy) and with no symptomatic intracranial haemorrhage. Successful recanalization is defined as achieving Thrombolysis In Myocardial Ischemia 2 or 3 flow in all treatable vessels. The primary safety end-point is the incidence of device-related and procedure-related serious adverse events. A major secondary efficacy end-point is time to achieve initial recanalization. Additional secondary end-points include clinical outcomes at 90 days and radiologic haemorrhagic transformation.
-
Randomized Controlled Trial Multicenter Study
EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke.
Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials. ⋯ With 750 patients per intervention group, this trial has 90% power to detect 7% absolute improvement at the 5% significance level. The full trial protocol is available at http://www.eurohyp1.eu. ClinicalTrials.gov Identifier: NCT01833312.
-
Randomized Controlled Trial
Targeted temperature management after intracerebral hemorrhage (TTM-ICH): methodology of a prospective randomized clinical trial.
Intracerebral hemorrhage causes 15% of strokes annually in the United States, and there is currently no effective therapy. ⋯ More research of novel therapies to improve outcomes after intracerebral hemorrhage is desperately needed. The results of the targeted temperature management after intracerebral hemorrhage clinical trial may provide additional information on the applicability of targeted temperature management after intracerebral hemorrhage.