Radial Artery Injury at Wrist and Hand LevelPhase 3NONERAONCT03622060
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
A Phase 3 study testing Nitroglycerin in people with Radial Artery Injury at Wrist and Hand Level and Occlusion of Artery, run by Hermina Heart Center Kemayoran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Radial Artery Injury at Wrist and Hand Level, Occlusion of Artery, Vasodilation
- What is being tested?
- Nitroglycerin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Jun 2018to 22 May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing transradial catheterization
Who cannot join
- Systolic blood pressure < 100 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Nitroglycerin
- Medical subject headings
- Arterial Occlusive Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroglycerinDrug
Also called Nicardipine
200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin | Active comparator | 500 microgram intraarterial Nitroglycerin Receives: Drug: Nitroglycerin |
| Nicardipine | Placebo comparator | 200 microgram intraraterial Nicardipine Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of antegrade radial artery flow by doppler evaluation
The absence of radial artery flow by doppler evaluation
Measured: 24 hour
Blood pressure change
Blood pressure change after drugs administration
Measured: 2 minutes after drugs administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start4 Jun 2018
- Primary completion21 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery Injury at Wrist and Hand LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- nitroglycerin and nicardipine
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hermina Heart Center Kemayoran
- Sponsor type
- University, hospital or other
- Collaborators
- Hermina Hospital Group
- Responsible party
- Principal investigator, Surya Dharma, MD, PhD, Hermina Heart Center Kemayoran
- Investigators
- Surya Dharma, MD, PhD, Principal investigator, Hermina Hospital Kemayoran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622060
- Sponsor's protocol ID
- HerminaHCK
- Acronym
- NONERAO
- Status last verified
- Jun 2019
- First submitted
- 1 Aug 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25179153
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization
- ClinicalTrials.gov ID
- NCT03622060
- Acronym / sponsor ID
- NONERAO / HerminaHCK
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hermina Heart Center KemayoranUniversity, hospital or other
- Collaborators
- Hermina Hospital Group
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- nitroglycerin and nicardipine
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin | Active comparator | Drug: Nitroglycerin500 microgram intraarterial Nitroglycerin |
| Nicardipine | Placebo comparator | Drug: Nitroglycerin200 microgram intraraterial Nicardipine |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing transradial catheterization
Key exclusion criteria (1 listed)
- Systolic blood pressure < 100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitroglycerinAlso: Nicardipine200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal | Drug | Nicardipine, Nitroglycerin |
Primary outcome
The absence of antegrade radial artery flow by doppler evaluation
Time frame: 24 hour
The absence of radial artery flow by doppler evaluation
Blood pressure change
Time frame: 2 minutes after drugs administration
Blood pressure change after drugs administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Results publication: PubMed 25179153Dharma 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surya Dharma, MD, PhD principal investigator
Hermina Hospital Kemayoran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitroglycerin in people with Radial Artery Injury at Wrist and Hand Level and Occlusion of Artery, run by Hermina Heart Center Kemayoran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of antegrade radial artery flow by doppler evaluation (time frame: 24 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.