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

June 18, 2020 updated by: Merck KGaA, Darmstadt, Germany

An Interventional, Pilot Study to Evaluate the Efficacy of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive CAD Patients (SPET Study)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nicorandil
Drug: Nicorandil
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12
Time Frame: Baseline, Week 12
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12
Time Frame: Baseline, Week 12
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Baseline, Week 12
Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12
Time Frame: Baseline, Week 12
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Baseline, Week 12
Change From Baseline in Ejection Fraction at Week 12
Time Frame: Baseline, Week 12
Echocardiography was used to measure ejection fraction.
Baseline, Week 12
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12
Time Frame: Baseline, Week 12
Echocardiography was used to measure LVESD.
Baseline, Week 12
Change From Baseline in Left Ventricular Wall Thickness at Week 12
Time Frame: Baseline, Week 12
Echocardiography was used to measure left ventricular wall thickness.
Baseline, Week 12
Change From Baseline in Cardiac Diastolic Function: Early [E] to Late [A] Ventricular Filling Velocities (E/A) Ratio at Week 12
Time Frame: Baseline, Week 12
Echocardiography was used to measure E/A ratio.
Baseline, Week 12
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12
Time Frame: Baseline, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Co., Ltd., China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2016

Primary Completion (ACTUAL)

July 9, 2019

Study Completion (ACTUAL)

July 9, 2019

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (ESTIMATE)

January 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200505_506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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