Trial Outcomes & Findings for Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion (NCT NCT01349491)
NCT ID: NCT01349491
Last Updated: 2017-04-27
Results Overview
To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
6 months
Results posted on
2017-04-27
Participant Flow
Participant milestones
| Measure |
Ranolazine
Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.
|
Placebo
Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
Baseline characteristics by cohort
| Measure |
Ranolazine
n=5 Participants
Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.
|
Placebo
n=5 Participants
Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.
|
Total
n=10 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.
Outcome measures
| Measure |
Ranolazine
n=5 Participants
Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.
|
Placebo
n=5 Participants
Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.
|
|---|---|---|
|
Primary Outcome - Number of Participants With Atrial Fibrillation
|
3 participants
|
3 participants
|
Adverse Events
Ranolazine
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
Stavros Stavrakis
University of Oklahoma Health Sciences Center
Phone: 405-271-9696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place