Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Pr. Semir Nouira

Status and phase: Completed; Phase 3

Conditions: Spasm Artery

Treatments: Drug: Nicardipine

Study type: Interventional

Funder types: Other

Identifiers

NCT04538534

TN2020-NA T -INS-39

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,500 participants in 2 patient groups

nicardipine and isosorbide dinitrate

Experimental group

Description:

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.

Treatment:

Drug: Nicardipine

isosorbide dinitrate

Active Comparator group

Description:

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

Treatment:

Drug: Nicardipine