Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Spasm Artery
• Intervention / Treatment: Drug: Nicardipine

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • CHU Fattouma Bourguiba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nicardipine and isosorbide dinitrate; 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; To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm; Other Names: Loxen
Active Comparator: isosorbide dinitrate; 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; To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm; Other Names: Loxen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in which severe radial artery spasm occurred	Complete catheter blockage [i.e., the catheter cannot be moved back or forth], severe pain with need for morphine or midazolam injections, crossover to the contralateral radial or femoral artery	24 hours

Collaborators and Investigators

• Sponsor: Pr. Semir Nouira

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: radial artery spasm
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Spasm; Muscle Cramp; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Nicardipine
• Other Study ID Numbers: TN2020-NA T -INS-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No