CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 328 enrolled
Drug / intervention
Nitroglycerin +1 moredrug
Likely dose
Nitroglycerin 200 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02343276
NCT02343276Phase 3Completed
CompareCT.gov

Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

Instituto de Cardiologia de Santa Catarina·interventional·Posted Jan 21, 2015·Updated May 31, 2019

In Brief

A Phase 3 clinical trial evaluating Nitroglycerin and Placebo for Cardiac Catheterisation. Completed, enrolled 328 participants across 1 site.

Detailed Summary

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group). Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Catheterisation
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 21, 2015
Enrollment StartFeb 1, 2015
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.4 years ago

Interventions

Nitroglycerindrug

Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion

Placeboother

Placebo (saline solution 10 ml) in radial artery after sheath insertion