Spasm ArteryPhase 3NCT04538534
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
A Phase 3 study testing Nicardipine in people with Spasm Artery, run by Pr. Semir Nouira at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasm Artery
- What is being tested?
- Nicardipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2020to 1 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Planned femoral approach because no radial pulse was perceived
- Cardiogenic shock
- Coronary intervention for ST elevation myocardial infarction during the night shift.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Spasm Artery
- Being tested
- Nicardipine
- Keywords
- radial artery spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Also called Loxen
To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm
| Study group | Role | What they receive |
|---|---|---|
| nicardipine and isosorbide dinitrate | Experimental | 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. Receives: Drug: Nicardipine |
| isosorbide dinitrate | Active comparator | 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 Receives: Drug: Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasm ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr. Semir Nouira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538534
- Sponsor's protocol ID
- TN2020-NA T -INS-39
- Status last verified
- Feb 2022
- First submitted
- 31 May 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04538534
- Acronym / sponsor ID
- TN2020-NA T -INS-39
- Conditions
- Spasm Artery
- Keywords
- radial artery spasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Pr. Semir NouiraUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicardipine and isosorbide dinitrate | Experimental | Drug: NicardipineA 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 | Active comparator | Drug: NicardipineIsosorbide 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Planned femoral approach because no radial pulse was perceived
- Cardiogenic shock
- Coronary intervention for ST elevation myocardial infarction during the night shift.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineAlso: LoxenTo compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm | Drug | isosorbide dinitrate, nicardipine and isosorbide dinitrate |
Primary outcome
Number of Participants in which radial artery spasm occurred
Time frame: 24 hours
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
1 secondary outcome
Number of Participants in which severe radial artery spasm occurred
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicardipine in people with Spasm Artery, run by Pr. Semir Nouira at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in which radial artery spasm occurred (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.