Trial Outcomes & Findings for Ranolazine in Ischemic Cardiomyopathy (NCT NCT01345188)
NCT ID: NCT01345188
Last Updated: 2024-12-09
Results Overview
Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
COMPLETED
PHASE4
28 participants
12 weeks
2024-12-09
Participant Flow
Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013
A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.
Participant milestones
| Measure |
Ranolazine, Then Placebo
Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks.
|
|---|---|
|
Randomization Ranolazine/Placebo 6 Weeks
STARTED
|
28
|
|
Randomization Ranolazine/Placebo 6 Weeks
COMPLETED
|
26
|
|
Randomization Ranolazine/Placebo 6 Weeks
NOT COMPLETED
|
2
|
|
Crossover Ranolazine/Placebo 6 Weeks
STARTED
|
26
|
|
Crossover Ranolazine/Placebo 6 Weeks
COMPLETED
|
25
|
|
Crossover Ranolazine/Placebo 6 Weeks
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ranolazine, Then Placebo
Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks.
|
|---|---|
|
Randomization Ranolazine/Placebo 6 Weeks
Withdrawal by Subject
|
2
|
|
Crossover Ranolazine/Placebo 6 Weeks
Lost to Follow-up
|
1
|
Baseline Characteristics
Ranolazine in Ischemic Cardiomyopathy
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=28 Participants
Includes both groups randomized to placebo and ranolazine
|
|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ejection Fraction
|
33.1 Percentage
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Diabetes Mellitus
|
19 participants
n=5 Participants
|
|
Prior myocardial infarction
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina
Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
Outcome measures
| Measure |
Ranolazine
n=24 Participants
|
Placebo
n=24 Participants
Patients that received placebo
|
|---|---|---|
|
Anginal Frequency
|
86.67 units on a scale
Interval 40.0 to 100.0
|
74.44 units on a scale
Interval 10.0 to 100.0
|
PRIMARY outcome
Timeframe: 12 weeksQuality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.
Outcome measures
| Measure |
Ranolazine
n=24 Participants
|
Placebo
n=24 Participants
Patients that received placebo
|
|---|---|---|
|
Quality of Life Questionnaire
|
72.22 units on a scale
Interval 50.0 to 92.0
|
66.67 units on a scale
Interval 42.0 to 92.0
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo
RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.
Outcome measures
| Measure |
Ranolazine
n=20 Participants
|
Placebo
n=20 Participants
Patients that received placebo
|
|---|---|---|
|
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
|
-0.45 units on a scale
Interval -4.0 to 2.0
|
-0.34 units on a scale
Interval -2.0 to 1.0
|
Adverse Events
Ranolazine
Placebo
Serious adverse events
| Measure |
Ranolazine
n=24 participants at risk
patients receiving ranolazine
|
Placebo
n=24 participants at risk
Patients receiving placebo
|
|---|---|---|
|
Cardiac disorders
Heart failure
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
|
Nervous system disorders
stroke
|
4.2%
1/24 • Number of events 1 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
Other adverse events
| Measure |
Ranolazine
n=24 participants at risk
patients receiving ranolazine
|
Placebo
n=24 participants at risk
Patients receiving placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
|
Nervous system disorders
diziness
|
12.5%
3/24 • Number of events 3 • 12 weeks
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
8.3%
2/24 • Number of events 2 • 12 weeks
|
0.00%
0/24 • 12 weeks
|
Additional Information
Dr Nicolas W Shammas
Midwest Cardiovascular Research Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place