Trial Outcomes & Findings for Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants (NCT NCT03010423)
NCT ID: NCT03010423
Last Updated: 2020-07-07
Results Overview
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
TERMINATED
PHASE4
8 participants
Baseline, Week 12
2020-07-07
Participant Flow
Participant milestones
| Measure |
Nicorandil
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Nicorandil
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
|
|---|---|
|
Overall Study
Study termination
|
8
|
Baseline Characteristics
Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants
Baseline characteristics by cohort
| Measure |
Nicorandil
n=8 Participants
Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
|
|---|---|
|
Age, Customized
Between >=18 and <= 70 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Myocardial blood flow is a measure of endothelial function measured by positron emission tomography.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Echocardiography was used to measure ejection fraction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Echocardiography was used to measure LVESD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Echocardiography was used to measure left ventricular wall thickness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
Echocardiography was used to measure E/A ratio.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.
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.
Outcome measures
Outcome data not reported
Adverse Events
Nicorandil
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place