Trial Outcomes & Findings for Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents (NCT NCT02147834)

Results Overview

The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Change in baseline to month 4

Results posted on

2019-06-11

Participant Flow

5 subjects enrolled. First subjected enrolled 8/7/2015 and last enrolled on 11/19/2015. enrollment discontinued early by investigator due to futility.

Participant milestones

Participant milestones
Measure	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 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: sugar pill manufactured to mimic 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
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranolazine n=3 Participants 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 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=2 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: sugar pill manufactured to mimic 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	Total n=5 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in baseline to month 4

Population: The investigator ended this project early due to futility. Do data was analyzed.

The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Compare from baseline to month 4

Population: The investigator ended this study early due to futility. no data was analyzed.

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 data not reported

SECONDARY outcome

Timeframe: 4 month

Population: The investigator ended this study early due to futility. No data was analyzed.

frequency of the number of reported adverse events for ischemia driven revascularization or hospitalization

Outcome measures

Outcome data not reported

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony A Bavry, M.D.

North Florida South Georigai Veteran Health System

Phone: 352-548-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place