Coronary Artery DiseasePhase 2NCT06289946
Topical Nitro or Placebo Pre-Cath
A Phase 2 study testing NitroBid in people with Coronary Artery Disease, run by Thomas Jefferson University.
Trial summary
Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- NitroBid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Mar 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female > 18 years of age at the time of consent
- Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
- Able to provide informed consent with capacity, given in English.
Who cannot join
- Patients with any of the following characteristics or conditions will not be included in the study:
- Known nitrate allergy
- Allergy to CeraVe Moisturizing lotion
- Baseline hypotension with systolic blood pressure <90mmHg
- Absence of radial artery blood flow in one or both arms
- Presence or history of liver, rheumatologic, or chronic kidney disease
Show all 10Show fewer
- Current treatment with any vasodilator therapy (eg. Sildenafil)
- Radial artery catheterization <30 days prior to enrollment
- Active site infection
- AV-fistula or prior radial artery harvest for bypass surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Topical Nitroglycerin Prior to Trans-radial Coronary Angiography: a Phase 2, Randomized Controlled Trial
Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.
Read the detailed description
Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.
- Conditions
- Coronary Artery Disease
- Being tested
- NitroBid, Placebo
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitroBidDrug
We will apply nirobid to the wrist prior to left heart catheterization.
PlaceboDrug
We will apply placebo moisturizing cream to the wrist
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Subject will get placebo Receives: Drug: Placebo |
| Nitro arm | Experimental | Subject will get Nitrobid Receives: Drug: NitroBid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossover rate
- Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289946
- Sponsor's protocol ID
- NitroRadialLHC
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nitroglycerin Prior to Trans-radial Coronary Angiography: a Phase 2, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06289946
- Acronym / sponsor ID
- NitroRadialLHC
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Mar 2024 (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.
Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.
Detailed description
Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Drug: PlaceboSubject will get placebo |
| Nitro arm | Experimental | Drug: NitroBidSubject will get Nitrobid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or non-pregnant female > 18 years of age at the time of consent
- Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
- Able to provide informed consent with capacity, given in English.
Key exclusion criteria (10 listed)
- Patients with any of the following characteristics or conditions will not be included in the study:
- Known nitrate allergy
- Allergy to CeraVe Moisturizing lotion
- Baseline hypotension with systolic blood pressure <90mmHg
- Absence of radial artery blood flow in one or both arms
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 |
|---|---|---|
| NitroBidWe will apply nirobid to the wrist prior to left heart catheterization. | Drug | Nitro arm |
| PlaceboWe will apply placebo moisturizing cream to the wrist | Drug | Placebo arm |
Primary outcome
Crossover rate
Time frame: 1 year
• Evaluate number of attempts needed prior to successful radial artery cannulation and need for conversion to transfemoral approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NitroBid in people with Coronary Artery Disease, run by Thomas Jefferson University.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael w Foster, MD (6107160962, mxf314@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crossover rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.