Coronary Artery DiseasePhase 4NCT05087797
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
A Phase 4 study testing nicorandil in people with Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- nicorandil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 8 Jul 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)
Who cannot join
- successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack.
Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO.
Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.
- Conditions
- Coronary Artery Disease
- Being tested
- nicorandil
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicorandilDrug
Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| nicorandil group | Experimental | Not described Receives: Drug: nicorandil |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
total area strain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start8 Apr 2019
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ming cui, doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087797
- Sponsor's protocol ID
- M2018253
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen S, Ma C, Feng X, Cui M. Nicorandil Improves Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion. Front Cardiovasc Med. 2022 May 12;9:864223. doi: 10.3389/fcvm.2022.864223. eCollection 2022.
PubMed 35647043
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT05087797
- Acronym / sponsor ID
- M2018253
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 21 Oct 2021 (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.
Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack.
Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO.
Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicorandil group | Experimental | Drug: nicorandil |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter)
Key exclusion criteria (1 listed)
- successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases
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 |
|---|---|---|
| nicorandilPatients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months | Drug | nicorandil group |
Primary outcome
total area strain
Time frame: 3 months
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 21 Oct 2021.
- Derived from this study: PubMed 35647043Chen S, Ma C, Feng X, Cui M. Nicorandil Improves Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion. Front Cardiovasc Med. 2022 May 12;9:864223. doi: 10.3389/fcvm.2022.864223. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
ming cui, doctor principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nicorandil in people with Coronary Artery Disease, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 21 Oct 2021. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
total area strain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087797, which also lists 1 linked publication.
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 21 Oct 2021.