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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 4

Conditions

Non-obstructive Coronary Artery Disease

Treatments

Drug: Nicorandil

Study type

Interventional

Funder types

Industry

Identifiers

NCT03010423

EMR200505_506

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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