Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Conditions

• Spasm Artery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Nov 1, 2020

Status verified

Feb 2022

Primary completion

Feb 1, 2022

Completion

Feb 1, 2022

Study Design

Enrollment

1,500 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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.
• 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

Primary Outcome Measure

Number of Participants in which radial artery spasm occurred [ Time Frame: 24 hours ]