Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion

NCT03622060 | Completed Phase 3 DMC

• 1 other identifier: HerminaHCK
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The absence of antegrade radial artery flow by doppler evaluation

  The absence of radial artery flow by doppler evaluation

  24 hour

• Blood pressure change

  Blood pressure change after drugs administration

  2 minutes after drugs administration

Study Arms (2)

Nitroglycerin

ACTIVE COMPARATOR

500 microgram intraarterial Nitroglycerin

Drug: Nitroglycerin

Nicardipine

PLACEBO COMPARATOR

200 microgram intraraterial Nicardipine

Drug: Nitroglycerin

Interventions

Nitroglycerin DRUG

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

Also known as: Nicardipine

Nicardipine; Nitroglycerin

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing transradial catheterization

You may not qualify if:

• Systolic blood pressure \< 100 mmHg

Sponsors & Collaborators

• Hermina Heart Center Kemayoran: lead
• Hermina Hospital Group: collaborator

Study Sites (1)

Hermina Heart Center

Jakarta Pusat, DKI Jakarta, 10630, Indonesia

Location

Related Publications (1)

• Dharma S, Kedev S, Patel T, Kiemeneij F, Gilchrist IC. A novel approach to reduce radial artery occlusion after transradial catheterization: postprocedural/prehemostasis intra-arterial nitroglycerin. Catheter Cardiovasc Interv. 2015 Apr;85(5):818-25. doi: 10.1002/ccd.25661. Epub 2014 Sep 13.

  PMID: 25179153 RESULT

MeSH Terms

Conditions

Arterial Occlusive Diseases; Aneurysm

Interventions

Nitroglycerin; Nicardipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Surya Dharma, MD, PhD

  Hermina Hospital Kemayoran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NONERAO study

Model Details: nitroglycerin and nicardipine

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 9, 2018
• Study Start: June 4, 2018
• Primary Completion: May 21, 2019
• Study Completion: May 22, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)