Trial Outcomes & Findings for Ranolazine Among Unrevascularized Chronic Stable Angina Patients (NCT NCT02265796)

Last Updated: 2019-08-22

Results Overview

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 of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and 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). .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Change in baseline to 16 weeks

Results posted on

2019-08-22

Participant Flow

recruitment period first subject enrolled 9/24/2014 to last subject enrolled 12/12/2015

Participant milestones

Participant milestones
Measure	Ranolazine Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Overall Study STARTED	25	25
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranolazine Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Overall Study Death	1	0
Overall Study started on excluded medication	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Ranolazine Among Unrevascularized Chronic Stable Angina Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine n=25 Participants Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=25 Participants Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Total n=50 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	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Hypertension	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Hyperlipidemia	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Diabetes mellitus	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
on Insulin	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
history of Percutaneous Coronary Intervention	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
history of Coronary Artery Bypass Graft surgery	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in baseline to 16 weeks

Population: by intention to treat, 46 subjects had baseline and follow up SAQ data completed at 16 weeks

Outcome measures

Outcome measures
Measure	Ranolazine n=22 Participants Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=24 Participants Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Physical Limitation baseline	48 units on a scale Standard Deviation 25	50 units on a scale Standard Deviation 20
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Physical Limitation 16 weeks	40 units on a scale Standard Deviation 19	60 units on a scale Standard Deviation 24
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Physical Limitation group difference	-7 units on a scale Standard Deviation 27	6 units on a scale Standard Deviation 20
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angina Stability baseline	39 units on a scale Standard Deviation 28	37 units on a scale Standard Deviation 28
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angina Stablility 16 weeks	58 units on a scale Standard Deviation 26	55 units on a scale Standard Deviation 27
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angia Stability group difference	19 units on a scale Standard Deviation 36	18 units on a scale Standard Deviation 32
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angina Frequency baseline	65 units on a scale Standard Deviation 24	64 units on a scale Standard Deviation 23
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angina Frequency 16 weeks	81 units on a scale Standard Deviation 23	80 units on a scale Standard Deviation 24
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Angina Frequency group difference	16 units on a scale Standard Deviation 36	15 units on a scale Standard Deviation 27
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Treatment Satisfaction baseline	80 units on a scale Standard Deviation 19	85 units on a scale Standard Deviation 18
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Treatment Statisfaction 16 weeks	77 units on a scale Standard Deviation 26	82 units on a scale Standard Deviation 22
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Treatment Satisfaciton group difference	-4 units on a scale Standard Deviation 26	-3 units on a scale Standard Deviation 26
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Quality of Life baseline	37 units on a scale Standard Deviation 24	45 units on a scale Standard Deviation 27
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Quality of Life 16 weeks	56 units on a scale Standard Deviation 29	63 units on a scale Standard Deviation 18
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks Quality of Life group difference	21 units on a scale Standard Deviation 32	18 units on a scale Standard Deviation 31

SECONDARY outcome

Timeframe: Compare from baseline to month 4

overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4

Outcome measures

Outcome measures
Measure	Ranolazine n=22 Participants Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=24 Participants Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Subjective Well Being Baseline · excellent/good	9 Participants	6 Participants
Subjective Well Being Baseline · fair/poor	12 Participants	16 Participants
Subjective Well Being Baseline · missing	1 Participants	2 Participants
Subjective Well Being 16 Weeks · excellent/good	11 Participants	10 Participants
Subjective Well Being 16 Weeks · fair/poor	10 Participants	10 Participants
Subjective Well Being 16 Weeks · missing	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 month

Population: the incidence of ischemia driven hospitalization or catheterization was assessed for all subjects.

Number of participants who reported adverse events for ischemia driven revascularization or hospitalization

Outcome measures

Outcome measures
Measure	Ranolazine n=25 Participants Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=25 Participants Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Ischemia Driven Revascularization or Hospitalization	3 Participants	5 Participants

Adverse Events

Ranolazine

Serious events: 5 serious events

Other events: 17 other events

Deaths: 1 deaths

Sugar Pill

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ranolazine n=25 participants at risk Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=25 participants at risk Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) lung mass	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders death	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders bradycardia, symptomatic	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders Unstable Angina	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Renal and urinary disorders Hematuria	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders Myocardial Infarctoin	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders chest pain	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Cardiac disorders coronary artery disease	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.

Other adverse events

Additional Information

Dr. Anthony Bavry

Malcom Randall VA Medical Center

Phone: 352-376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ranolazine n=25 participants at risk Ranolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Ranolazine: Ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks	Sugar Pill n=25 participants at risk Sugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks Sugar pill: 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks
Psychiatric disorders anxiety	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Nervous system disorders dizziness	20.0% 5/25 • Number of events 5 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Respiratory, thoracic and mediastinal disorders Bronchitis	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Nervous system disorders Fainting	12.0% 3/25 • Number of events 3 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	8.0% 2/25 • Number of events 2 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.0% 2/25 • Number of events 2 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	12.0% 3/25 • Number of events 3 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Renal and urinary disorders worsening renal function	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Musculoskeletal and connective tissue disorders Leg cramps	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Gastrointestinal disorders Diarrhea	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	8.0% 2/25 • Number of events 2 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 2 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Nervous system disorders Lethargy	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Musculoskeletal and connective tissue disorders Fall	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Respiratory, thoracic and mediastinal disorders productive cough	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Nervous system disorders Confusion	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.
Gastrointestinal disorders Black stools	0.00% 0/25 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.	4.0% 1/25 • Number of events 1 • Baseline to 16 weeks adverse events assessed at 1 week, 4 week and 16 week phone call follow-up.