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Sponsor terminated study due to lack of enrollment
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The investigators will test if upfront dosing of Ranolazine can reduce myocardial biomarker release (CK-MB, Troponin) post percutaneous coronary intervention (PCI).
Ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. Furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. It has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (PCI).
We hypothesize that upfront administration of Ranolazine could decrease the myocardial injury associated with PCI due to all the factors listed above (i.e. precondition the myocardium). We plan to screen all patients scheduled for an elective coronary angiogram. Those who meet criteria and consent will be randomized to either receive Ranolazine or placebo twice a day for 3 days leading up to the PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Oral treatment Intervention: Drug: Ranolazine 1000 mg |
|
| Placebo | Placebo Comparator | Oral treatment Intervention: Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Troponin | Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | 8-10 hrs post PCI |
| CK-MB | CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | 8-10 hrs post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI Flow Rate (Grade) | This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory] *(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harvey S Hahn, MD | Kettering Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI |
| FG001 | Placebo | Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI |
| BG001 | Placebo | Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI |
| 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 | Troponin | Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test. | Posted | Number | NG/ML | 8-10 hrs post PCI |
|
Adverse event data was collected from time of consent through end of study discharge from hospital. Adverse events unresolved at discharge were to be followed to resolution. No events occuring after discharge were to be recorded as adverse events.
Study timeline consisted of consent, pre-procedure medication (3 days), arrival for out-patient heart cath procedure, possible PCI, post-procedure recovery time, and discharge from hospital recovery room. Time from consent to start of study meds varied. Time from start of study drug to discharge was 4 days.
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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 | Oral treatment Intervention: Drug: Ranolazine 1000 mg Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Coleman, PhD | Kettering Health Network | 937-395-8390 | suzanne.coleman@khnetwork.org |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 | Drug: Placebo Oral dose twice per day for 3 days leading up to PCI |
|
| TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure. |
| Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab | Abnormal heart activity | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire |
| Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI | Following completion of PCI through hospital discharge |
| Left Ventricular End Diastolic Pressure (LVEDP) | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire |
| Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest | At discharge or within 1 days, whichever comes first |
| Death, MI, Revascularization, CHF | 1-4 weeks post PCI |
| Successful PCI | For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI. | At discharge or within 1 days, whichever comes first |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral treatment Intervention: Drug: Placebo
Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
|
|
| Primary | CK-MB | CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first | For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test. | Posted | 8-10 hrs post PCI |
|
|
| Secondary | TIMI Flow Rate (Grade) | This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory] *(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade. | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected. | Posted | Number | units on a scale | TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure. |
|
|
|
| Secondary | Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab | Abnormal heart activity | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected. | Posted | Number | participants | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire |
|
|
|
| Secondary | Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected. | Posted | Number | participants | Following completion of PCI through hospital discharge |
|
|
|
| Secondary | Left Ventricular End Diastolic Pressure (LVEDP) | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected. | Posted | Number | mmHG | During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire |
|
|
|
| Secondary | Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected. | Posted | Number | participants | At discharge or within 1 days, whichever comes first |
|
|
|
| Secondary | Death, MI, Revascularization, CHF | Posted | Number | participants | 1-4 weeks post PCI |
|
|
|
| Secondary | Successful PCI | For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI. | The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected. | Posted | Number | participants | At discharge or within 1 days, whichever comes first |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Placebo | Oral treatment Intervention: Drug: Placebo Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI | 0 | 2 | 0 | 2 |
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| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |