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The study was terminated early, due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China.
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| Name | Class |
|---|---|
| Merck Serono Co., Ltd., China | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicorandil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorandil | Drug | Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12 |
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Inclusion criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono Co., Ltd., China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union medical college hospital | Beijing | China |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicorandil | Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2018 | Jun 18, 2020 |
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Myocardial blood flow is a measure of endothelial function measured by positron emission tomography. |
| Baseline, Week 12 |
| Change From Baseline in Ejection Fraction at Week 12 | Echocardiography was used to measure ejection fraction. | Baseline, Week 12 |
| Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12 | Echocardiography was used to measure LVESD. | Baseline, Week 12 |
| Change From Baseline in Left Ventricular Wall Thickness at Week 12 | Echocardiography was used to measure left ventricular wall thickness. | 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. | 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. | Baseline, Week 12 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicorandil | Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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, therefore the data could not be extracted and hence data reported here is as per the total range reflecting in the inclusion criteria. | Number | Participants |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Ejection Fraction at Week 12 | Echocardiography was used to measure ejection fraction. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12 | Echocardiography was used to measure LVESD. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Left Ventricular Wall Thickness at Week 12 | Echocardiography was used to measure left ventricular wall thickness. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12 |
|
| |||||||||||||||||||
| 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. | 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. | Posted | Baseline, Week 12 |
|
|
Up to 15 months
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. Thus, data for adverse event was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicorandil | Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2019 | Jun 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020108 | Nicorandil |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D009930 | Organic Chemicals |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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