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

Non-obstructive Coronary Artery Disease Clinical Trial

— SPET  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03010423
• Other study ID #: EMR200505_506
• Status: Terminated
• Phase: Phase 4
• Start date: November 30, 2016
• Est. completion date: July 9, 2019

Study information

• Verified date: June 2020
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Non-obstructive Coronary Artery Disease

Intervention

Drug:
• Nicorandil
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Merck Serono Co., Ltd., China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12	Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.	Baseline, Week 12
Secondary	Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12	Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.	Baseline, Week 12
Secondary	Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12	Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.	Baseline, Week 12
Secondary	Change From Baseline in Ejection Fraction at Week 12	Echocardiography was used to measure ejection fraction.	Baseline, Week 12
Secondary	Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12	Echocardiography was used to measure LVESD.	Baseline, Week 12
Secondary	Change From Baseline in Left Ventricular Wall Thickness at Week 12	Echocardiography was used to measure left ventricular wall thickness.	Baseline, Week 12
Secondary	Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12	Echocardiography was used to measure E/A ratio.	Baseline, Week 12
Secondary	Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12	Seattle angina questionnaire (SAQ) score will be classified into five dimensions: physical limitation (question 1), anginal stability (question 2), anginal frequency (question 3-4), treatment satisfaction (question 5-8) and disease perception (question 9-11). Individual dimensions of the SAQ are transformed into the standard score between 0 and 100. The range of scores was 0 to 100, with higher scores indicates better functioning.	Baseline, Week 12

External Links

•   Trial Awareness and Transparency website