Overview

Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pr. Semir Nouira
Treatments:
Nicardipine
Criteria
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.