AUTHOR=Diamanti Susanna , Beretta Simone , Tettamanti Mauro , Sacco Simona , Sette Giuliano , Ornello Raffaele , Tiseo Cindy , Caponnetto Valeria , Beccia Mario , Alivernini Diletta , Costanzo Rocco , Ferrarese Carlo 

TITLE=Multi-Center Randomized Phase II Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9): Study Design and Protocol

JOURNAL=Frontiers in Neurology

VOLUME=Volume 12 - 2021

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.724050

DOI=10.3389/fneur.2021.724050

ISSN=1664-2295

ABSTRACT=Aim: Assess the efficacy of remote ischemic conditioning (RIC) in patients with ischemic stroke within 9 hours of onset that are not candidate to recanalization therapies.
Sample size estimates: A sample size of 80 patients (40 in each arm) should yield 80% power to detect a 20% difference in early neurological improvement at 72 hours at p=0.05, two sided.
Methods and design: TRICS-9 is a phase II, multicenter, controlled, block randomized, open-label, interventional clinical trial. Patients recruited in Italian academic hospitals will be randomized 1:1 to either RIC plus standard medical therapy or standard medical therapy alone. After randomization, RIC will be applied manually by four alternating cycles of inflation/deflation 5 minutes each, using a blood pressure cuff around the non-paretic arm.
Study outcomes: The primary efficacy outcome is early neurological improvement, defined as the percent change in National Institute of Health Stroke Scale (NIHSS) at 72 hours in each arm. Secondary outcomes include: early neurologic improvement at 24 and 48 hours; disability at 3 months; rate of symptomatic intracerebral hemorrhage; feasibility (proportion of patients completing RIC); tolerability after RIC and at 72 hours; blood levels of HIF-1α and HSP27 at 24 hours and 72 hours.
Discussion/conclusion: RIC in combination with recanalization therapies appears to add no clinical benefit to patients, but whether it is beneficial to those that are not candidate to recanalization therapies is still to be demonstrated. TRICS-9 has been developed to elucidate this issue.
Trial registration number: registered with ClinicalTrials.gov, NCT04400981.