Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants
Condition: Non-obstructive Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Nicorandil
Intervention description: Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
Intervention MeSH terms: Nicorandil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Non-obstructive coronary artery disease; Nicorandil

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.
    

Eligibility criteria:

        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