A Phase 3 interventional study of Nicardipine in Spasm Artery, sponsored by Pr. Semir Nouira. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Pr. Semir Nouira · Phase 3, Interventional, and Prevention
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.
Exclusion Criteria:
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: 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
Also known as: Loxen
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
Time frame: 24 hours
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
Time frame: 24 hours
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Pr. Semir Nouira