Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

NCT04538534 | Completed Phase 3 DMC

• 1 other identifier: TN2020-NA T -INS-39
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. The success of the radial approach is therefore of a paramount importance. However, radial artery spasm (RAS) remains one of the major limitations of transradial approach (TRA) and the most frequent cause of TRA failure. Several recommendations has been issued to improve success rate when using the radial route. In the Tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that RAS and TRA failure has subsequently increased. The standard and only used protocol by the Tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent RAS. Nicardipine is the only injectable calcium antagonist available in Tunisia. Its spasmolytic action on radial artery has been well demonstrated when used in CABG. However, it has been very poorly investigated in trans radial percutaneous coronary intervention. Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only.

Conditions

Spasm Artery

Keywords

radial artery spasm

Outcome Measures

Primary Outcomes (1)

• Number of Participants in which radial artery spasm occurred

  Significant limitation of the catheter movement perceived by the operator together with mild to severe pain in the forearm of the patient or the need of repeating vasodilator administration

  24 hours

Secondary Outcomes (1)

• Number of Participants in which severe radial artery spasm occurred

  24 hours

Study Arms (2)

nicardipine and isosorbide dinitrate

EXPERIMENTAL

A Cocktail of 1 mg of Isosorbide Dinitrate associated to 1 mg of nicardipine will be put in a syringe than diluted in saline serum to have a volume of 3cc. The obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization.

Drug: Nicardipine

isosorbide dinitrate

ACTIVE COMPARATOR

Isosorbide Dinitrate: 1 mg will be diluted in saline solution as to have a 3cc volume The obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization

Drug: Nicardipine

Interventions

Nicardipine DRUG

To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm

Also known as: Loxen

isosorbide dinitrate; nicardipine and isosorbide dinitrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty).
• Participant is willing and is able to give informed consent for participating in the trial.
• Male or Female, aged 18 years or above.

You may not qualify if:

• Planned femoral approach because no radial pulse was perceived
• Cardiogenic shock
• Coronary intervention for ST elevation myocardial infarction during the night shift.

Sponsors & Collaborators

• Pr. Semir Nouira: lead

Study Sites (1)

CHU Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

MeSH Terms

Interventions

Nicardipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: September 4, 2020
• Study Start: November 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)