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Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03622060
Acronym
NONERAO
Enrollment
600
Registered
2018-08-09
Start date
2018-06-04
Completion date
2019-05-22
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed description

Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described. The internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol. Radial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.

Interventions

DRUGNitroglycerin

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

Sponsors

Hermina Hospital Group
CollaboratorUNKNOWN
Hermina Heart Center Kemayoran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Double blind

Intervention model description

nitroglycerin and nicardipine

Eligibility

Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* All patients undergoing transradial catheterization

Exclusion criteria

* Systolic blood pressure \< 100 mmHg

Design outcomes

Primary

MeasureTime frameDescription
The absence of antegrade radial artery flow by doppler evaluation24 hourThe absence of radial artery flow by doppler evaluation
Blood pressure change2 minutes after drugs administrationBlood pressure change after drugs administration

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026