Clinical trial NCT03010423: Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants
Official title: An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Non-obstructive Coronary Artery Disease
Keywords: Non-obstructive coronary artery disease
Nicorandil
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2017-01-05
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Ejection Fraction at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Left Ventricular Wall Thickness at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
Study officials:
affiliation: Merck Serono Co., Ltd., China
name: Medical Responsible
role: STUDY_DIRECTOR
References: