Not provided
Not provided
Not provided
Not provided
Not provided
lack of enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beaumont Foundation of America | OTHER |
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery
A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft [CABG], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG surgery with Ranolazine | Active Comparator | Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Ranolazine 1000 mg (2-500mg tablets) twice daily. 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 (1-500mg tablet) twice daily. |
|
| CABG surgery with placebo | Placebo Comparator | Patient will undergo Coronary Artery Bypass Graft (open heart surgery) and will receive, Placebo 1000mg mg (2-500mg tablets)twice daily. 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 500mg (1-500mg tablet) twice daily. |
|
| Heart Valve surgery with Ranolazine | Active Comparator | Patient will undergo heart Valve surgery and will receive, Ranolazine1000mg (2-500 mg tablets) 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 (1-500mg tablet) twice a day. |
|
| Heart Valve surgery with placebo | Placebo Comparator | Patient will undergo heart Valve surgery and will receive, Placebo 1000mg (2-500mg tablets) 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 500mg (1-500mg tablet) twice a day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. 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 500mg (1-500mg tablet) twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period. | 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. | The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ilana Kutinsky, DO | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| William Beaumont Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment started October 2010 and completed November 2012
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects scheduled/undergoing cardiac surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine and Patients Having Heart Bypass 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period. | 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. | Study was prematurely terminated. Data for this Outcome Measure were not collected | Posted | The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged |
|
All unexpected Adverse Events will be reported for the duration of the study. Subjects were followed and monitored for 30 days (duration of participation). Adverse events were collected for 2 years. Study was prematurely terminated.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine and Patients Having Heart Bypass 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 |
Not provided
Not provided
Early termination due to lack of enrollment. 15 pts enrolled, 6 withdrawn due breathing tube not removed by 10 pm day of surgery. 1 withdrawn after day 3 as he was in afib and placed on amio. All pts were male.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ilana Kutinsky, DO | William Beaumont Hospital | 248-267-5050 | ikutinsky@beaumont.edu |
Not provided
| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
|
| Placebo | Drug | Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. 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 500mg (1-500mg tablet) twice daily |
|
|
| Troy |
| Michigan |
| 48085-1198 |
| United States |
| BG001 | Placebo Pill and Patients Having Heart Bypass 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 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 |
| BG002 | Ranolazine and Patients Having Non Heart Bypass 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 |
| BG003 | Placebo Pill and Patients Having Non Heart Bypass 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 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo 2 pills twice daily with CABG |
| OG002 | Ranolazine Without CABG | Ranolazine 500 mg 2 pills twice daily without CABG |
| OG003 | Placebo Without CABG | Placebo 2 pills twice daily without CABG |
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo Pill and Patients Having Heart Bypass 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 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 | 0 | 7 | 0 | 7 |
| EG002 | Ranolazine and Patients Having Non Heart Bypass 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 | 0 | 2 | 0 | 2 |
| EG003 | Placebo Pill and Patients Having Non Heart Bypass 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 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 | 0 | 2 | 0 | 2 |
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |