Non-obstructive Coronary Artery Disease
Conditions
Keywords
Non-obstructive coronary artery disease, Nicorandil
Brief 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.
Interventions
DRUGNicorandil
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
Sponsors
Merck Serono Co., Ltd., China
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12 | Baseline, Week 12 | Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12 | Baseline, Week 12 | Myocardial blood flow is a measure of endothelial function measured by positron emission tomography. |
| Change From Baseline in Ejection Fraction at Week 12 | Baseline, Week 12 | Echocardiography was used to measure ejection fraction. |
| Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12 | Baseline, Week 12 | Echocardiography was used to measure LVESD. |
| Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12 | Baseline, Week 12 | Myocardial blood flow is a measure of endothelial function measured by positron emission tomography. |
| Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12 | Baseline, Week 12 | Echocardiography was used to measure E/A ratio. |
| Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12 | Baseline, 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. |
| Change From Baseline in Left Ventricular Wall Thickness at Week 12 | Baseline, Week 12 | Echocardiography was used to measure left ventricular wall thickness. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicorandil Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study termination | 8 |
Baseline characteristics
| Characteristic | Nicorandil |
|---|---|
| Age, Customized Between >=18 and <= 70 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
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.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
Change From Baseline in Ejection Fraction at Week 12
Echocardiography was used to measure ejection fraction.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Echocardiography was used to measure LVESD.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Echocardiography was used to measure left ventricular wall thickness.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
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.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
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.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Secondary
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.
Time frame: Baseline, Week 12
Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.