Topical Nitro or Placebo Pre-Cath

NCT ID: NCT06289946

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-31

Brief 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 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo arm

Subject will get placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

We will apply placebo moisturizing cream to the wrist

Nitro arm

Subject will get Nitrobid

Group Type: EXPERIMENTAL

NitroBid

Intervention Type: DRUG

We will apply nirobid to the wrist prior to left heart catheterization.

Interventions

NitroBid

We will apply nirobid to the wrist prior to left heart catheterization.

Intervention Type: DRUG

Placebo

We will apply placebo moisturizing cream to the wrist

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or non-pregnant female > 18 years of age at the time of consent

2. Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory

3. Able to provide informed consent with capacity, given in English.

Exclusion Criteria

Patients with any of the following characteristics or conditions will not be included in the study:

1. Known nitrate allergy

2. Allergy to CeraVe Moisturizing lotion

3. Baseline hypotension with systolic blood pressure <90mmHg

4. Absence of radial artery blood flow in one or both arms

5. Presence or history of liver, rheumatologic, or chronic kidney disease

6. Current treatment with any vasodilator therapy (eg. Sildenafil)

7. Radial artery catheterization <30 days prior to enrollment

8. Active site infection

9. AV-fistula or prior radial artery harvest for bypass surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Michael w Foster, MD

Role: CONTACT

mxf314@jefferson.edu

6107160962

Other Identifiers

NitroRadialLHC

Identifier Type: -

Identifier Source: org_study_id