Trial Outcomes & Findings for The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure (NCT NCT01887353)

NCT ID: NCT01887353

Last Updated: 2015-07-20

Results Overview

There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2015-07-20

Participant Flow

Participant milestones

Measure	Ranolazine Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily	Placebo Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Overall Study STARTED	4	4
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Ranolazine Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily	Placebo Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Overall Study Study stopped early	4	3

Baseline Characteristics

The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Baseline characteristics by cohort

Measure	Ranolazine n=4 Participants Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily	Placebo n=4 Participants Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.	Total n=8 Participants Total of all reporting groups
Age, Continuous	89.7 years STANDARD_DEVIATION 9.5 • n=5 Participants	78.9 years STANDARD_DEVIATION 8.9 • n=7 Participants	84.3 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 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	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead

Outcome measures

Measure	Ranolazine n=4 Participants Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily	Placebo n=4 Participants Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Time to First Atrial Fibrillation (AF) Recurrence	0 participants	2 participants

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ranolazine n=4 participants at risk Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily	Placebo n=4 participants at risk Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Cardiac disorders Medication intolerance	25.0% 1/4 • Entire study duration (up to 6 months or until stoppage).	50.0% 2/4 • Entire study duration (up to 6 months or until stoppage).

Additional Information

T. Jared Bunch

Intermountain Healthcare

Phone: 8015074701

Email: jared.bunch@imail.org

Results disclosure agreements

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