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

Phase 4

Terminated

• Conditions: Non-obstructive Coronary Artery Disease
• Interventions: Drug: Nicorandil

• Registration Number: NCT03010423
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-30
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Status Verified: 2020-06
• Results First Submitted: 2020-06-18
• Results First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Results First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicorandil	Nicorandil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12	Baseline, 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	Baseline, 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	Baseline, Week 12	Echocardiography was used to measure ejection fraction.
Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12	Baseline, Week 12	Echocardiography was used to measure LVESD.
Change From Baseline in Left Ventricular Wall Thickness at Week 12	Baseline, 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	Baseline, Week 12	Echocardiography was used to measure E/A ratio.
Change From Baseline in Seattle Angina Questionnaire(SAQ) Score at Week 12	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.

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, China