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

• Status: Terminated
• Trial end date: 2019-07-09
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd., China
• Treatments: Nicorandil

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