Trial intelligence / Profile preview

Subcutaneous Administration of Nitroglycerin to Facilitate Trans-radial Access in Coronary Procedures

NCT03304496Phase 4

Key facts

Status: Suspended
Start: Mar 2018
Primary completion: Mar 2019
Countries: 1
Sponsor: Instituto Nacional de Cardiología Ignacio Chávez
Modality: Small Molecules

Drugs: nitroglycerin
Conditions: coronary artery disease (CAD)

Overview

Phase 4, randomised, double-blind trial of nitroglycerin in coronary artery disease (CAD) (2 arms), sponsored by Instituto Nacional de Cardiología Ignacio Chávez. Primary endpoint: Compound of crossover to femoral access and/or access site-related vascular complications. Started Mar 2018; status: suspended.

Design

2 arms

Study design: RandomizedDouble-blind

Nitroglycerin
Subcutaneous injection of 0.5 ml of 500 mcg nitroglycerin + 1 ml of 2% lidocaine.
Control
Subcutaneous injection of 0.5 ml of 0.9% saline + 1 ml of 2% lidocaine.

Who it enrols

Adults scheduled for a coronary procedure with planned right or left radial artery access and a positive modified Allen or Barbeau test. Excludes pregnant women, patients with acute myocardial infarction with ST segment elevation in the first 12 hours, complicated acute coronary syndrome, and those who have taken PDE5 inhibitors within 72 hours.

Endpoints

Primary

Compound of crossover to femoral access and/or access site-related vascular complicationshospital discharge

Secondary

Number of attempts to cannulate the radial artery (punctures)1 year
Time until obtaining the radial access1 year
Improvement in radial pulse strength1 year
Loss of radial artery flow (radial artery occlusion) at 30 days30 days
Pain in the cannulated extremity1 year
Radial spasmDuring coronary procedure
HeadacheDuring coronary procedure
Hypotension10 minutes

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