Trial Outcomes & Findings for Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery (NCT NCT01352416)
NCT ID: NCT01352416
Last Updated: 2017-01-06
Results Overview
Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged
Results posted on
2017-01-06
Participant Flow
Recruitment started October 2010 and completed November 2012
Participant milestones
| Measure |
Ranolazine and Patients Having CABG Surgery
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Sugar Pill and Patients Having CABG Surgery
2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses
|
Ranolazine With Patients Having Non CABG Heart Surgery
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Sugar Pills and Patients Having Non CABG Heart Surgery
2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
2
|
2
|
|
Overall Study
COMPLETED
|
3
|
5
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Ranolazine and Patients Having CABG Surgery
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Sugar Pill and Patients Having CABG Surgery
2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses
|
Ranolazine With Patients Having Non CABG Heart Surgery
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Sugar Pills and Patients Having Non CABG Heart Surgery
2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.
Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
2
|
1
|
Baseline Characteristics
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Ranolazine and Patients Having Heart Bypass Surgery
n=4 Participants
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Placebo Pill and Patients Having Heart Bypass Surgery
n=7 Participants
2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Ranolazine and Patients Having Non Heart Bypass Surgery
n=2 Participants
500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Placebo Pill and Patients Having Non Heart Bypass Surgery
n=2 Participants
2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses
|
Total
n=15 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 25.5 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
63.4 years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
15 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolongedPopulation: Study was prematurely terminated. Data for this Outcome Measure were not collected
Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.
Outcome measures
Outcome data not reported
Adverse Events
Ranolazine and Patients Having Heart Bypass Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and Patients Having Heart Bypass Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ranolazine and Patients Having Non Heart Bypass Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and Patients Having Non Heart Bypass Surgery
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place