Trial Outcomes & Findings for Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD (NCT NCT01754259)
NCT ID: NCT01754259
Last Updated: 2017-07-24
Results Overview
Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-07-24
Participant Flow
The order of ranolazine and placebo exposure was randomly assigned in a 1:1 ratio by the Investigational Drug Service at BWH. During the 28-day treatment periods, ranolazine and matching placebo were administered as 500 mg by mouth twice daily for 1 week and increased to 1000 mg by mouth twice daily for 3 weeks, as tolerated.
Participant milestones
| Measure |
Ranolazine
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Ranolazine
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
Baseline characteristics by cohort
| Measure |
Ranolazine
n=23 Participants
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
n=24 Participants
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksChange (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.
Outcome measures
| Measure |
Ranolazine
n=23 Participants
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
n=24 Participants
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Change in Post-exercise Coronary Vasodilator Reserve
|
-4 % change
|
2 % change
|
SECONDARY outcome
Timeframe: 4 weeksChange (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E') at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e'), septal and lateral peak systolic tissue velocity (s'), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines.
Outcome measures
| Measure |
Ranolazine
n=23 Participants
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
n=24 Participants
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Change in LV Diastolic Function
|
1 % change
|
-2 % change
|
Adverse Events
Ranolazine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranolazine
n=23 participants at risk
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
n=24 participants at risk
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Nervous system disorders
Fall complicated by non-fatal intracerebral hemorrhage
|
0.00%
0/23 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
Other adverse events
| Measure |
Ranolazine
n=23 participants at risk
subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
Placebo
n=24 participants at risk
Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor.
|
|---|---|---|
|
Nervous system disorders
Nausea and Dizziness
|
39.1%
9/23 • Number of events 9 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
0.00%
0/24 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Endocrine disorders
Hypoglycemia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
0.00%
0/24 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Renal abnormality
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
0.00%
0/24 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Hepatobiliary disorders
Transaminitis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
0.00%
0/24 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/23 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Chest pain requiring evaluation
|
0.00%
0/23 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
0.00%
0/24 • Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place