Trial Outcomes & Findings for Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation (NCT NCT01590979)

NCT ID: NCT01590979

Last Updated: 2017-03-23

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 3 weeks after surgery
• Results posted on: 2017-03-23

Participant Flow

Participant milestones

Measure	Ranolazine The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals	Placebo Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals
Overall Study STARTED	27	27
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

Baseline characteristics by cohort

Measure	Ranolazine n=27 Participants The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals	Placebo n=27 Participants Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals	Total n=54 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	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	65.7 years STANDARD_DEVIATION 11.7 • n=5 Participants	62.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	64.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks after surgery

Population: Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.

Outcome measures

Measure	Ranolazine n=27 Participants The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals	Placebo n=27 Participants Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals
Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients	5 Participants	8 Participants

Adverse Events

Ranolazine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ranolazine n=27 participants at risk The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. Ranolazine: 1000mg, two times a day, 12 hour intervals	Placebo n=27 participants at risk Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals) Placebo: two times a day, 12 hour intervals
Gastrointestinal disorders Constipation	0.00% 0/27 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.	7.4% 2/27 • Number of events 2 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.
Gastrointestinal disorders Nausea	11.1% 3/27 • Number of events 3 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.	3.7% 1/27 • Number of events 1 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.
General disorders Dizziness	3.7% 1/27 • Number of events 1 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.	0.00% 0/27 • Post op (days 1-6); hospital discharge; Post -op follow up (2-3 weeks); Follow up call (day 28). Patients were given a medication log post discharge to note when medication was taken and to note any other comments related to how they were feeling.

Additional Information

Soad Bekheit, MD

Staten Island University Hospital, Northwell Health

Phone: 718-226-6629

Email: msills@northwell.edu

Results disclosure agreements

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