AUTHOR=Cai Lipeng , Rajah Gary , Duan Honglian , Gao Jie , Cheng Zhe , Xin Ruiqiang , Jiang Shangqian , Palmer Peter , Geng Xiaokun , Ding Yuchuan 

TITLE=Rapid Intravenous Glyceryl Trinitrate in Ischemic Damage (RIGID) After Stroke: Rationale, Design and Protocol for a Prospective Randomized Controlled Trial

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.693330

DOI=10.3389/fneur.2021.693330

ISSN=1664-2295

ABSTRACT=<p><bold>Background:</bold> Despite intravenous thrombolysis and endovascular therapy for acute ischemic stroke (AIS), many survivors still have varying degrees of disability. Glyceryl trinitrate (GTN), a nitric oxide (NO) donor, has been previously reported to induce neuroprotection after AIS. The use of GTN to reduce brain damage after stroke remains yet to be elucidated. This study was designed to explore the safety, feasibility, and preliminary efficacy of intravenous administration of GTN after AIS.</p><p><bold>Methods:</bold> A prospective randomized controlled trial is proposed with AIS patients. Participants will be randomly allocated to GTN group and control group with a 1:1 ratio (<italic>n</italic> = 40). Both groups will be treated with standard therapies according to the current stroke guidelines. Participants allocated to the GTN group will receive intravenous administration of GTN (5 mg GTN in 50 ml saline at a rate of 0.4 mg/h that is continued for 12.5 h/day for 2 days) within 24 h of symptom onset. Participants allocated to the control group will receive intravenous administration at equal capacity of 0.9% normal saline (NS) (total 50 ml/day at 4 ml/h that is continued for 12.5 h/day for 2 days). The primary outcome is safety [systolic blood pressure (SBP) &lt;110 mmHg, headache], while the secondary outcomes include changes in functional outcome and infarction volume.</p><p><bold>Discussion:</bold> Rapid Intravenous Glyceryl Trinitrate in Ischemic Damage (RIGID) is a prospective randomized controlled trial that aims to ascertain the safety, feasibility, and preliminary efficacy of intravenous GTN as a neuroprotection strategy after AIS. These results will provide parameters for future studies as well as provide insights into treatment effects. Any possible neuroprotective qualities of GTN in AIS will also be elucidated.</p><p><bold>Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://www.chictr.org.cn" xmlns:xlink="http://www.w3.org/1999/xlink">www.chictr.org.cn</ext-link>, identifier: ChiCTR2100046271.</p>