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Difficultly in enrolling
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Patients will take ranolazine 1000 mg tablets twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Atrial Fibrillation (AF) Recurrence | 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 | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| T. Jared Bunch, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84107-5701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily |
| FG001 | Placebo | Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily |
| BG001 | Placebo | Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time to First Atrial Fibrillation (AF) Recurrence | 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 | Posted | Number | participants | up to 6 months |
|
Entire study duration (up to 6 months or until stoppage).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine | Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication intolerance | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| T. Jared Bunch | Intermountain Healthcare | 8015074701 | jared.bunch@imail.org |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo |
| Drug |
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Placebo | Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. | 0 | 4 | 2 | 4 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |