Trial Outcomes & Findings for Microvascular Coronary Disease In Women: Impact Of Ranolazine (NCT NCT00570089)

Results Overview

Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

4 weeks and 10 weeks

Results posted on

2019-06-10

Participant Flow

20 subjects were recruited at Cedars-Sinai Medical Center Cardiology outpatient clinic.

This is a cross-over study. 20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.

Participant milestones

Participant milestones
Measure	Study Drug Ranexa Then Placebo 20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.	Placebo Then Study Drug Ranexa 20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
Period 1 STARTED	10	10
Period 1 COMPLETED	10	10
Period 1 NOT COMPLETED	0	0
Perod 2 STARTED	10	10
Perod 2 COMPLETED	10	10
Perod 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microvascular Coronary Disease In Women: Impact Of Ranolazine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=20 Participants Participants who were randomized to receive either Study drug Ranexa or Placebo.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks and 10 weeks

Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 4th week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion defect in percentage.

Outcome measures

Outcome measures
Measure	Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2) n=20 Participants CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.	Placebo - CMRs (10 CMR 1 and 10 CMR 2) n=20 Participants CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
Cardiac Magnetic Resonance (CMRs)	11.7 Percentage of ischemic myocardium Interval 8.0 to 19.3	16.0 Percentage of ischemic myocardium Interval 8.6 to 22.7

SECONDARY outcome

Timeframe: 4 weeks and 10 weeks

Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period. The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important. Each final SAQ domain ranges from 0-100, where higher is a better outcome score. Subscales are not combined. Median, SD and range are calculated for each domain.

Outcome measures

Outcome measures
Measure	Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2) n=20 Participants CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.	Placebo - CMRs (10 CMR 1 and 10 CMR 2) n=20 Participants CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
Seattle Angina Questionnaire (SAQ) Physical Functioning	91.7 units on a scale Interval 79.2 to 97.9	83.3 units on a scale Interval 66.6 to 97.2
Seattle Angina Questionnaire (SAQ) Angina Stability	75 units on a scale Interval 50.0 to 100.0	50 units on a scale Interval 25.0 to 75.0
Seattle Angina Questionnaire (SAQ) Angina Frequency	80 units on a scale Interval 50.0 to 100.0	75 units on a scale Interval 60.0 to 87.5
Seattle Angina Questionnaire (SAQ) Treatment Satisfaction	87.5 units on a scale Interval 75.0 to 100.0	93.8 units on a scale Interval 75.0 to 100.0
Seattle Angina Questionnaire (SAQ) Quality of Life	75 units on a scale Interval 60.4 to 83.3	66.7 units on a scale Interval 58.3 to 75.0

Adverse Events

Study Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

C. Noel Bairey Merz, MD

Cedars-Sinai Medical Center

Phone: 310-423-9680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place