CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,040 enrolled
Drug / intervention
Nitroglycerin I +3 moredrug
Likely dose
Nitroglycerin 500 microgram intra-arterially: 500 mcg at sheath placement and 500 mcg before sheath removalAI-extracted
Key inclusion· 3
  • ✓Indication for cardiac catheterization
  • ✓Suitable candidates for transradial approach
  • ✓Use of 5 or 6 French sheath in the procedure
Key exclusion· 5
  • ✕Unable to tolerate nitrates or known allergy to nitrates
  • ✕Use of any nitrate within 1 hour before the procedure
  • ✕ST-segment elevation acute myocardial infarction patients during the first 12 hours of symptom onset
  • ✕Intubated patients (on mechanical ventilation)

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

Search/NCT03158532
NCT03158532Phase 3Completed
CompareCT.gov

Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

Instituto de Cardiologia de Santa Catarina·interventional·Posted May 18, 2017·Updated Dec 9, 2024

In Brief

A Phase 3 clinical trial evaluating Nitroglycerin I, Placebo I, and 2 other interventions for Injury of Radial Artery. Completed, enrolled 2,040 participants across 3 sites.

Detailed Summary

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInjury of Radial Artery
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartJul 6, 2017
Primary CompletionOct 1, 2021
Study CompletionNov 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.1 years ago

Interventions

Nitroglycerin Idrug

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Placebo Idrug

Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.

Nitroglycerin IIdrug

500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Placebo IIdrug

Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.