Trial Outcomes & Findings for Ranolazine and Microvascular Angina by PET in the Emergency Department (NCT NCT02052011)
NCT ID: NCT02052011
Last Updated: 2017-05-16
Results Overview
Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-05-16
Participant Flow
This study was conducted from June, 2014-November, 2015 at the Yale New Haven Hospital Chest Pain Center, an ED observation unit that treats low-moderate cardiac risk patients.
Participant milestones
| Measure |
Intervention Group
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
|
Placebo Control
Subjects will take placebo pill twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
10
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Intervention Group
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
|
Placebo Control
Subjects will take placebo pill twice daily for 4 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Ranolazine and Microvascular Angina by PET in the Emergency Department
Baseline characteristics by cohort
| Measure |
Intervention Group
n=21 Participants
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
|
Placebo Control
n=10 Participants
Subjects will take placebo pill twice daily for 4 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 7 • n=5 Participants
|
50 years
STANDARD_DEVIATION 5 • n=7 Participants
|
50 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
TIMI Score
0-1
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
TIMI Score
2-3
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
TIMI Score
4-7
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksCompare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.
Outcome measures
| Measure |
Intervention Group
n=17 Participants
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
|
Placebo Control
n=8 Participants
Subjects will take placebo pill twice daily for 4 weeks.
|
|---|---|---|
|
Coronary Flow Reserve
Baseline CFR
|
1.6 ratio
Standard Deviation 0.3
|
1.6 ratio
Standard Deviation 0.3
|
|
Coronary Flow Reserve
Post-Treatment CFR
|
1.9 ratio
Standard Deviation 0.4
|
1.6 ratio
Standard Deviation 0.4
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=21 participants at risk
Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
|
Placebo Control
n=10 participants at risk
Subjects will take placebo pill twice daily for 4 weeks.
|
|---|---|---|
|
General disorders
Dizziness
|
14.3%
3/21
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place