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Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

Primary Purpose

Spasm Artery

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Nicardipine
Sponsored by
Pr. Semir Nouira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spasm Artery focused on measuring radial artery spasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Fattouma Bourguiba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nicardipine and isosorbide dinitrate

isosorbide dinitrate

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2020
Last Updated
February 6, 2022
Sponsor
Pr. Semir Nouira
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1. Study Identification

Unique Protocol Identification Number
NCT04538534
Brief Title
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Official Title
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pr. Semir Nouira

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasm Artery
Keywords
radial artery spasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nicardipine and isosorbide dinitrate
Arm Type
Experimental
Arm 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.
Arm Title
isosorbide dinitrate
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Nicardipine
Other Intervention Name(s)
Loxen
Intervention Description
To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm
Primary Outcome Measure Information:
Title
Number of Participants in which radial artery spasm occurred
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants in which severe radial artery spasm occurred
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHU Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

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Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention

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