Injury of Radial ArteryPhase 3PatensNCT03158532

Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

A Phase 3 study testing Nitroglycerin I and Nitroglycerin II in people with Injury of Radial Artery, run by Instituto de Cardiologia de Santa Catarina at 3 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Injury of Radial Artery
What is being tested?: Nitroglycerin I and Nitroglycerin II
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,040 participants
Where: 3 sitesBrazil
Study dates: 6 Jul 2017to 1 Nov 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Indication for cardiac catheterization;
Suitable candidates for transradial approach;
Use of 5 or 6 French sheath in the procedure;
Signed informed consent.

Who cannot join

Unable to tolerate nitrates or known allergy to nitrates;
Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
Intubated patients (on mechanical ventilation);
Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);
Prior inclusion in this trial.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

Hospital Universitário Professor Polydoro Ernani de São Thiago
Florianópolis, Santa Catarina, 88036-800
Irmandade Santa Casa Misericórdia Marília
Marília, São Paulo, 17515-900
Instituto de Cardiologia de Santa Catarina
São Jose, Santa Catarina, 88000

Other trials in Brazil

About this study

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

Read the detailed description

Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.

Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.

A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.

Conditions: Injury of Radial Artery
Being tested: Nitroglycerin I, Placebo I, Nitroglycerin II, Placebo II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nitroglycerin IDrug
Also called Tridil
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Placebo IDrug
Also called Saline
Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
Nitroglycerin IIDrug
Also called Tridil
500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo IIDrug
Also called Saline
Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.

Study groups in NCT03158532
Study group	Role	What they receive
Placebo I/Placebo II	Placebo comparator	0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Receives: Drug: Placebo I; Drug: Placebo II
Nitroglycerin I/Placebo II	Experimental	500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Receives: Drug: Nitroglycerin I; Drug: Placebo II
Placebo I /Nitroglycerin II	Active comparator	0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Receives: Drug: Placebo I; Drug: Nitroglycerin II
Nitroglycerin I /Nitroglycerin II	Experimental	500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Receives: Drug: Nitroglycerin I; Drug: Nitroglycerin II

What is being measured

The primary outcome is the main question the study is designed to answer.

Radial Artery Occlusion
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound
Measured: 2 to 24 hours after procedure

Secondary outcomes (5)

Late Radial Artery Occlusion
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound
Measured: 30 days after procedure
Pain Assessment
Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)
Measured: up to 24 hours after procedure
Spasm (Operator Evaluation)
Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure
Measured: During the realization of the procedure
Procedure Duration
Total duration of the procedure in seconds, from puncture to haemostatic dressing.
Measured: Duration of the procedure
Radiation Exposure
Total radiation used in the procedure
Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 20171 Nov 2021

First posted18 May 2017
Study start6 Jul 2017
Primary completion1 Oct 2021
Study completion1 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Injury of Radial ArteryStudies 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: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,040 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03158532
Sponsor's protocol ID: Nitroglycerin on Occlusion
Acronym: Patens
Status last verified: Dec 2024
First submitted: 16 May 2017
Last updated: 9 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Injury of Radial Artery trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
ClinicalTrials.gov ID: NCT03158532
Acronym / sponsor ID: Patens / Nitroglycerin on Occlusion
Conditions: Injury of Radial Artery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,040 participants (actual)
Lead sponsor: Instituto de Cardiologia de Santa CatarinaUniversity, hospital or other
Study start: 6 Jul 2017 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 18 May 2017 (actual)
Results: Posted 9 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo I/Placebo II	Placebo comparator	Drug: Placebo I, Drug: Placebo II0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Nitroglycerin I/Placebo II	Experimental	Drug: Nitroglycerin I, Drug: Placebo II500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Placebo I /Nitroglycerin II	Active comparator	Drug: Placebo I, Drug: Nitroglycerin II0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).
Nitroglycerin I /Nitroglycerin II	Experimental	Drug: Nitroglycerin I, Drug: Nitroglycerin II500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Indication for cardiac catheterization;
Suitable candidates for transradial approach;
Use of 5 or 6 French sheath in the procedure;
Signed informed consent.

Key exclusion criteria (6 listed)

Unable to tolerate nitrates or known allergy to nitrates;
Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
Intubated patients (on mechanical ventilation);
Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);

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
Nitroglycerin IAlso: Tridil500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.	Drug	Nitroglycerin I /Nitroglycerin II, Nitroglycerin I/Placebo II
Placebo IAlso: SalineSaline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.	Drug	Placebo I /Nitroglycerin II, Placebo I/Placebo II
Nitroglycerin IIAlso: Tridil500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.	Drug	Nitroglycerin I /Nitroglycerin II, Placebo I /Nitroglycerin II
Placebo IIAlso: SalineSaline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.	Drug	Nitroglycerin I/Placebo II, Placebo I/Placebo II

Primary outcome

Radial Artery Occlusion
Time frame: 2 to 24 hours after procedure
Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

5 secondary outcomes

Late Radial Artery Occlusion
Time frame: 30 days after procedure
Pain Assessment
Time frame: up to 24 hours after procedure
Spasm (Operator Evaluation)
Time frame: During the realization of the procedure
Procedure Duration
Time frame: Duration of the procedure
Radiation Exposure
Time frame: During the procedure

Results and safety

Results posted to the registry on 9 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo I/Placebo II	510	510
Nitroglycerin I/Placebo II	510	510
Placebo I /Nitroglycerin II	510	510
Nitroglycerin I /Nitroglycerin II	510	510

Primary outcome: Radial Artery Occlusion

Time frame: 2 to 24 hours after procedure. Count of participants. Unit: Participants

Measure	Placebo I/Placebo II n = 510	Nitroglycerin I/Placebo II n = 510	Placebo I /Nitroglycerin II n = 510	Nitroglycerin I /Nitroglycerin II n = 510
Value	13	13	10	13

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 1.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo I/Placebo II	0 of 510 (0%)	6 of 510 (1.2%)	0 of 510
Nitroglycerin I/Placebo II	0 of 510 (0%)	12 of 510 (2.4%)	0 of 510
Placebo I /Nitroglycerin II	0 of 510 (0%)	6 of 510 (1.2%)	0 of 510
Nitroglycerin I /Nitroglycerin II	0 of 510 (0%)	13 of 510 (2.5%)	0 of 510

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Injury of Radial Artery

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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.

Roberto L da Silva, MD study chair

Instituto de Cardiologia de Santa Catarina

José R Costa Júnior, PhD study director

Instituto Dante Pazzanese de Cardiologia

3 sites 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 I and Nitroglycerin II in people with Injury of Radial Artery, run by Instituto de Cardiologia de Santa Catarina at 3 sites in Brazil.

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 4 inclusion and 6 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil. 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?

Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Radial Artery Occlusion (time frame: 2 to 24 hours after procedure). 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 NCT03158532.

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 9 Dec 2024.