drugset / Trial / NCT06289946

Topical Nitro or Placebo Pre-Cath

NCT06289946

Phase 2 Unknown 256 enrolled Thomas Jefferson University
RandomizedSingle-groupDouble-blindTreatment

Summary

Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.

Timeline

Start
2024-03-01
Primary completion
2025-03-01
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitroglycerin Unknown Topical