Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion (NONERAO)

June 1, 2019 updated by: Surya Dharma, MD, PhD, Hermina Heart Center Kemayoran

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10630
        • Hermina Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing transradial catheterization

Exclusion Criteria:

  • Systolic blood pressure < 100 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitroglycerin
500 microgram intraarterial Nitroglycerin
Drug: Nitroglycerin
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
Other Names:
  • Nicardipine
Placebo Comparator: Nicardipine
200 microgram intraraterial Nicardipine
Drug: Nitroglycerin
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
Other Names:
  • Nicardipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The absence of antegrade radial artery flow by doppler evaluation
Time Frame: 24 hour
The absence of radial artery flow by doppler evaluation
24 hour
Blood pressure change
Time Frame: 2 minutes after drugs administration
Blood pressure change after drugs administration
2 minutes after drugs administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hermina Heart Center Kemayoran

Collaborators

Hermina Hospital Group

Investigators

  • Principal Investigator: Surya Dharma, MD, PhD, Hermina Hospital Kemayoran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2018

Primary Completion (Actual)

May 21, 2019

Study Completion (Actual)

May 22, 2019

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HerminaHCK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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