Clinical Trial Details
Glyceryl Trinitrate for Pre-hospital Ultra-acute Stroke: Main Results From the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial-2 (RIGHT-2)
RIGHT-2 is a clinical trial assessing the safety and efficacy of transdermal glyceryl trinitrate (GTN) patches vs. placebos for patients suffering acute stroke when administered ultra-acutely by paramedics in the pre-hospital setting.
Transdermal glyceryl trinitrate compared to sham, started by paramedics to lower BP before hospital admission and continued over the next 3 days, in very early presumed stroke did not improve functional outcomes and may have worsened outcomes for those with hemorrhagic stroke.
Purpose: to evaluate the safety and effectiveness of a glyceryl trinitrate (GTN) path given first by paramedics in the ambulance to lower BP before hospital admission and then over the next 3 days to patients with ischemic stroke(IS) or intracerebral hemorrhage (ICH).
Trial Design: Phase 3, UK, multicenter, 1:1 randomized, prospective, blinded endpoint trial; 1149 patients with presumed IS or ICH randomized to 5 mg. transdermal GTN or sham patch first given by paramedics within 4 hours of symptom onset and daily over the next 3 days. 8 Ambulance Services/54 hospitals. Mean age 73. 52% male. IS 52%, ICH 13%, TIA 9%, mimic 26%; onset to randomization median 71 minutes. Systolic BP ≥ 120 mm Hg. Cohort 1: patients with TIA or stroke. Cohort 2: all intention to treat patients.
Primary Endpoints: modified Rankin Scale (mRS) shift at 3 months. (90 days)
|mRS score||Cohort 1: acOR 1.25, p=0.083
Cohort 2: acOR 1.104, p=0.69
Lowered systolic BP 5.8mm Hg vs sham; p<0.0001
Lowered diastolic BP 2.6 mm Hg vs sham; p=0.0026
|Serious adverse events||188 patients||177 patients||P=0.16|
Results: Transdermal glyceryl trinitrate compared to sham in very early presumed stroke did not improve stroke outcomes and may have worsened outcomes for those with hemorrhagic stroke.
RIGHT-2: Interview with PI Philip Bath
Louise McCullough, MD, PhD interviews Philip Bath, MD, DSc, principal investigator of the RIGHT-2 trial, about the prehospital administration of TNG in ultra-acute stroke.
Primary endpoints, Efficacy
- Cohort 1, mRS score in AIS/TIA: 1adjusted common odds ratio (acOR) 1.25, p=0.083
- Cohort 2, mRS in all: acOR 1.04, p=0.69
- BP: GTS lowered systolic BP 5.8 mm Hg vs sham; p<0.0001 and diastolic BP 2.6 mmHg vs sham; p=0.0026
- Death in AIS/TIA: 36 deaths GTN; 23 deaths sham; p=0.091
- Serious adverse events: 188 GTN; 170 sham; p=0.16
Trial Design: Phase 3, UK, multicenter, randomized 1:1, prospective, blinded endpoint trial; randomized to 5 mg. transdermal GTN or sham patch first given by paramedics within 4 hours of symptom onset and daily over the next 3 days. 8 Ambulance Services/54 hospitals. Onset to randomization median 71 minutes.
Trial population: 1149 patients with presumed IS or ICH. Mean age 73. 52% male. IS 52%, ICH 13%, TIA 9%, mimic 26%. Systolic BP ≥ 120 mm Hg.
- Cohort 1: patients with TIA or stroke
- Cohort 2: all intention to treat patients
Primary endpoint: modified Rankin Scale (mRS) shift at 3 months (90 days).
Sponsors and Collaborators— British Heart Foundation
- Presented by Philip M Bath at International Stroke Conference 2019, Honolulu, Hawaii
- RIGHT-2 Website
- Bath's Abstract
- Bath's Presentation Slides (PDF)
- Published in The Lancet: Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): an ambulance-based, randomised, sham-controlled, blinded, phase 3 trial
Blood pressure, stroke, intracerebral hemorrhage, paramedic, glyceryl trinitrate
Related Clinical Topics
Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Globin Zinc Insulin, Insulin, Benzocaine, Hypoglycemic Agents, Physiological Effects of Drugs, Anesthetics, Local Anesthetics, Central Nervous System Depressants, Sensory System Agents, Peripheral Nervous System Agents