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

Primary Purpose

Non-obstructive Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nicorandil
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-obstructive Coronary Artery Disease focused on measuring Non-obstructive coronary artery disease, Nicorandil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Peking union medical college hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nicorandil

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change From Baseline in Ejection Fraction at Week 12
Echocardiography was used to measure ejection fraction.
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Echocardiography was used to measure LVESD.
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Echocardiography was used to measure left ventricular wall thickness.
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.
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.

Full Information

First Posted
January 3, 2017
Last Updated
June 18, 2020
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China
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1. Study Identification

Unique Protocol Identification Number
NCT03010423
Brief Title
Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early, due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China.
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Coronary Artery Disease
Keywords
Non-obstructive coronary artery disease, Nicorandil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicorandil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
Description
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
Description
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
Description
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Ejection Fraction at Week 12
Description
Echocardiography was used to measure ejection fraction.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Description
Echocardiography was used to measure LVESD.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Description
Echocardiography was used to measure left ventricular wall thickness.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
Description
Echocardiography was used to measure E/A ratio.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
Description
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.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Serono Co., Ltd., China
Official's Role
Study Director
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=EMR200505_506
Description
Trial Awareness and Transparency website

Learn more about this trial

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

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