Non-obstructive Coronary Artery DiseasePhase 4SPETNCT03010423
Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants
A Phase 4 study testing Nicorandil in people with Non-obstructive Coronary Artery Disease, run by Merck KGaA, Darmstadt, Germany at 1 site in China.
Trial summary
The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Non-obstructive 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
- 8 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2016to 9 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Participants aged 18-70 years
- Participants with typical stable angina but without coronary obstruction (defined as coronary occlusion less than (<) 50%) by invasive coronary angiography or coronary computed tomography angiography (CTA) in recent three months
- All other long acting cardiovascular disease medicines, including but not limited to aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins, ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before screening period
- For participants who met these four criteria above, MFR will be tested by stress PET. Participants whose MFR <3.0 could be included in the study
Who cannot join
- Severe or uncontrolled hypertension (resting Systolic blood pressure [SBP] >=160 millimeter of mercury (mmHg), or resting Diastolic blood pressure [DBP] >=100mmHg at screening period)
- Participants with shock (including cardiogenic shock), or hypovolemia
- Severe hypotension (resting SBP<90mmHg，or resting DBP<60mmHg)
- Significant valvular heart disease, congenital heart disease or cardiomyopathy
- Congestive heart failure(New York Heart Association [NYHA] III-IV), echocardiographic ejection fraction<45%
- Acute pulmonary edema;
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- Hepatic or renal dysfunction, defined as:
- Serum Alanine Aminotransferase (ALT) > triple of the normal value upper limit;
- Serum Aspartate Aminotransferase (AST) > triple of the normal value upper limit
- Serum creatinine > twice of the normal value upper limit
- Glaucoma
- Active peptic ulcer or active skin ulcer
- Taking glyburide, phosphodiesterase type 5 (PDE-5) inhibitor, soluble guanylate cyclase stimulator(s)
- Known to be hypersensitivity to nicorandil, nitrates, niacin, or any of the excipient
- With contraindication to complete stress PET test
- No legal ability and legal ability is limited
- Participants unlikely to cooperate in the study or with inability or unwillingness to give informed consent
- Child-bearing period women without effective contraceptive measures, pregnancy and lactation
- Participation in another clinical trial within the past 30 days
- Other significant disease that in the Investigator's opinion would exclude the participant from the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)
The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.
- Conditions
- Non-obstructive Coronary Artery Disease
- Being tested
- Nicorandil
- Keywords
- Non-obstructive coronary artery disease, Nicorandil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicorandilDrug
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil | Experimental | Not described Receives: Drug: Nicorandil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
Measured: Baseline, Week 12
Secondary outcomes (7)
Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Measured: Baseline, Week 12
Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Measured: Baseline, Week 12
Change From Baseline in Ejection Fraction at Week 12
Echocardiography was used to measure ejection fraction.
Measured: Baseline, Week 12
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Echocardiography was used to measure LVESD.
Measured: Baseline, Week 12
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Echocardiography was used to measure left ventricular wall thickness.
Measured: Baseline, Week 12
Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
Echocardiography was used to measure E/A ratio.
Measured: Baseline, Week 12
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start30 Nov 2016
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Why it stopped: The study was terminated early, due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-obstructive Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono Co., Ltd., China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010423
- Sponsor's protocol ID
- EMR200505_506
- Acronym
- SPET
- Status last verified
- Jun 2020
- First submitted
- 3 Jan 2017
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)
- ClinicalTrials.gov ID
- NCT03010423
- Acronym / sponsor ID
- SPET / EMR200505_506
- Conditions
- Non-obstructive Coronary Artery Disease
- Keywords
- Non-obstructive coronary artery disease, Nicorandil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early, due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Co., Ltd., China
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicorandil | Experimental | Drug: Nicorandil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Participants aged 18-70 years
- Participants with typical stable angina but without coronary obstruction (defined as coronary occlusion less than (<) 50%) by invasive coronary angiography or coronary computed tomography angiography (CTA) in recent three months
- All other long acting cardiovascular disease medicines, including but not limited to aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins, ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before screening period
- For participants who met these four criteria above, MFR will be tested by stress PET. Participants whose MFR <3.0 could be included in the study
Key exclusion criteria (20 listed)
- Severe or uncontrolled hypertension (resting Systolic blood pressure [SBP] >=160 millimeter of mercury (mmHg), or resting Diastolic blood pressure [DBP] >=100mmHg at screening period)
- Participants with shock (including cardiogenic shock), or hypovolemia
- Severe hypotension (resting SBP<90mmHg，or resting DBP<60mmHg)
- Significant valvular heart disease, congenital heart disease or cardiomyopathy
- Congestive heart failure(New York Heart Association [NYHA] III-IV), echocardiographic ejection fraction<45%
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 |
|---|---|---|
| NicorandilParticipants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. | Drug | Nicorandil |
Primary outcome
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
Time frame: Baseline, Week 12
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
7 secondary outcomes
Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Ejection Fraction at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
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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.
Medical Responsible study director
Merck Serono Co., Ltd., China
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 Non-obstructive Coronary Artery Disease, run by Merck KGaA, Darmstadt, Germany 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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 7 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12 (time frame: Baseline, Week 12). 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 7 Jul 2020.