Trial Outcomes & Findings for Ranolazine Mediated PVC Reduction in Ischemic Heart Disease (NCT NCT02360397)

NCT ID: NCT02360397

Last Updated: 2020-01-29

Results Overview

The change in percentage of PVC burden after taking Ranolazine 1000mg twice daily for 30 days

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline (7 day) Holter compared to day 30 (7 day) Holter
• Results posted on: 2020-01-29

Participant Flow

Participant milestones

Measure	Ranolazine Ranolazine 1000 mg tablet twice daily for 30 days ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Ranolazine Ranolazine 1000 mg tablet twice daily for 30 days ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days
Overall Study Incomplete screening	3
Overall Study Adverse Event	1

Baseline Characteristics

Ranolazine Mediated PVC Reduction in Ischemic Heart Disease

Baseline characteristics by cohort

Measure	Ranolazine n=6 Participants Ranolazine 1000 mg tablet twice daily for 30 days ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	78 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (7 day) Holter compared to day 30 (7 day) Holter

Population: The percentage of PVC's on Holter monitor at baseline compared to day 30 were used to determine the statistical significance of the data.

The change in percentage of PVC burden after taking Ranolazine 1000mg twice daily for 30 days

Outcome measures

Measure	Ranolazine n=2 Participants Ranolazine 1000 mg tablet twice daily for 30 days
The Effect of Ranolazine on the PVC Burden Over 30 Days percentage of PVC burden at Baseline	5.71 percentage of PVC burden Interval 5.52 to 9.73
The Effect of Ranolazine on the PVC Burden Over 30 Days percentage of PVC burden at Day 30	5.495 percentage of PVC burden Interval 1.2 to 9.73

PRIMARY outcome

Timeframe: Baseline and day 30

The effect of ranolazine on cardiac ischemia as measured by change in millimeters of ST segment deviation on ECG monitoring at Baseline and after 30 days of Ranolazine therapy (day 30).

Outcome measures

Measure	Ranolazine n=2 Participants Ranolazine 1000 mg tablet twice daily for 30 days
The Effect of Ranolazine on Cardiac Ischemia	0 millimeters Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline and day 30

Population: Score on Seattle Angina Questionnaire at Baseline and at day 30.

The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). Angina symptoms may be felt as: chest pain, a heaviness, tightness or squeezing sensation in the chest, aching across the chest, particularly behind the breastbone. The pain may radiate to the neck, jaw, arms, back or teeth.

Outcome measures

Measure	Ranolazine n=2 Participants Ranolazine 1000 mg tablet twice daily for 30 days
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Baseline SAQ score for Angina Frequency	95 score on a scale Interval 90.0 to 100.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Day 30 SAQ score for Angina Frequency	95 score on a scale Interval 90.0 to 100.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Baseline score for Angina Stability	50 score on a scale Interval 50.0 to 50.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Day 30 SAQ score for Angina Stability	50 score on a scale Interval 50.0 to 50.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Baseline SAQ score for Physical Limitation	94.445 score on a scale Interval 88.89 to 100.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Day 30 SAQ score for Physical Limitation	94.445 score on a scale Interval 88.89 to 100.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Baseline SAQ score for Day 30 SAQ score Quality of	79.165 score on a scale Interval 58.33 to 100.0
Score on Seattle Angina Questionnaire at Baseline and at Day 30 Day 30 SAQ score for Quality of Life	87.5 score on a scale Interval 75.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and Day 30

Number of non-sustained ventricular tachycardia episodes (>8 beats) and sustained ventricular arrhythmia episodes on Holter monitoring at baseline and at 30 days

Outcome measures

Measure	Ranolazine n=2 Participants Ranolazine 1000 mg tablet twice daily for 30 days
Number of Non-sustained Ventricular Tachycardia and Sustained Ventricular Arrhythmia Episodes on Holter Monitoring Baseline Holter	0 number of episodes
Number of Non-sustained Ventricular Tachycardia and Sustained Ventricular Arrhythmia Episodes on Holter Monitoring Day 30 Holter	0 number of episodes

Adverse Events

Ranolazine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranolazine n=6 participants at risk Ranolazine 1000 mg tablet twice daily for 30 days ranolazine: Ranolazine 1000 mg tablet twice daily for 30 days
Cardiac disorders Syncopy	16.7% 1/6 • Number of events 1 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Chester M. Hedgepeth, MD, PhD

Brigham and Women's Cardiovascular Associates at Kent Hospital

Phone: (401) 737-7010

Email: chedgepeth@kentri.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place