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Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

NCT03622060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-06-04

No results posted yet for this study

Summary

A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of \>95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.

Conditions

  • Radial Artery Injury at Wrist and Hand Level
  • Occlusion of Artery
  • Vasodilation

Interventions

DRUG

Nitroglycerin

200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal

Sponsors & Collaborators

  • Hermina Hospital Group

    collaborator UNKNOWN

  • Hermina Heart Center Kemayoran

    lead OTHER

Principal Investigators

  • Surya Dharma, MD, PhD · Hermina Hospital Kemayoran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2019-05-21
Completion
2019-05-22

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622060 on ClinicalTrials.gov