Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants

Study Overview
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Brief Summary
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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.

Official Title
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An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)

Conditions
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Non-obstructive Coronary Artery Disease

Intervention / Treatment
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* Drug: Nicorandil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicorandil<br> | Drug: Nicorandil<br>* Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-obstructive coronary artery disease, Nicorandil