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

Launched by MERCK KGAA, DARMSTADT, GERMANY · Jan 4, 2017

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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