Trial Outcomes & Findings for Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome (NCT NCT02252406)

NCT ID: NCT02252406

Last Updated: 2020-04-10

Results Overview

Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Change from baseline to 24 weeks
• Results posted on: 2020-04-10

Participant Flow

Recruitment period: 7/21/14 - 7/2/18 Location: UF Jacksonville Outpatient Cardiology clinic

Participant milestones

Measure	Ranolazine Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Ranolazine: Ranolazine 500 mg from baseline to week 3 Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24.	Placebo Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Placebo: Matching placebo tablets daily for 24 weeks.
Starting Dose Ranolazine 500 mg BID STARTED	16	17
Starting Dose Ranolazine 500 mg BID COMPLETED	12	14
Starting Dose Ranolazine 500 mg BID NOT COMPLETED	4	3
Titrated to Ranolazine 1000mg BID STARTED	12	14
Titrated to Ranolazine 1000mg BID COMPLETED	9	13
Titrated to Ranolazine 1000mg BID NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Ranolazine Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Ranolazine: Ranolazine 500 mg from baseline to week 3 Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24.	Placebo Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Placebo: Matching placebo tablets daily for 24 weeks.
Starting Dose Ranolazine 500 mg BID Lost to Follow-up	2	3
Starting Dose Ranolazine 500 mg BID Withdrawal by Subject	1	0
Starting Dose Ranolazine 500 mg BID Adverse Event	1	0
Titrated to Ranolazine 1000mg BID Lost to Follow-up	1	1
Titrated to Ranolazine 1000mg BID Adverse Event	2	0

Baseline Characteristics

Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome

Baseline characteristics by cohort

Measure	Ranolazine n=16 Participants Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy. Ranolazine: Ranolazine 500 mg from baseline to week 3 Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24.	Placebo n=17 Participants Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy. Placebo: Matching placebo tablets daily for 24 weeks.	Total n=33 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	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	17 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 24 weeks

Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)

Outcome measures

Measure	Ranolazine Treated n=9 Participants We looked women randomized by table randomization to ranolazine that successfully titrated to maximum dose of tested drug (1,000 mg bid)	Placebo n=13 Participants We looked women randomized by table randomization to placebo that successfully titrated to maximum dose of placebo drug
Impact of Ranolazine on Hemoglobin A1C	-5 percent change Standard Deviation 6.2	2.6 percent change Standard Deviation 9.1

PRIMARY outcome

Timeframe: Change from Baseline to 24 weeks

Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome

Outcome measures

Measure	Ranolazine Treated n=9 Participants We looked women randomized by table randomization to ranolazine that successfully titrated to maximum dose of tested drug (1,000 mg bid)	Placebo n=13 Participants We looked women randomized by table randomization to placebo that successfully titrated to maximum dose of placebo drug
Impact of Ranolazine on HDL-C Levels in Subjects	6.6 percentage of change in HDL Standard Deviation 15.7	6.5 percentage of change in HDL Standard Deviation 46.6

Adverse Events

Ranolazine Treated

Serious events: 0 serious events

Other events: 3 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

Measure	Ranolazine Treated n=16 participants at risk Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy	Placebo n=17 participants at risk Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.
Gastrointestinal disorders upset stomach	18.8% 3/16 • Number of events 3 • Patients were followed for 24 weeks	0.00% 0/17 • Patients were followed for 24 weeks

Additional Information

Gladys Velarde, MD

University of Florida, Jacksonville

Phone: 904-244-2060

Email: gladys.velarde@jax.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place