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Sponsor can not supply drugs anymore.
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To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atorvastatin | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours. | Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazen Abu-Fadel, M.D. | Oklahoma Univeristy Health Science Center and VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma University Health Science Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| Veterans Affairs Medical Center |
No data was collected; therefore, a plan is not applicable.
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Prior to assigning participants to specific arms of the protocol, site was informed that the study drug was no longer available.
Participants were recruited and signed consent. No drugs were supplied to participants. Study sponsor could not provide study drugs to participants due to cost restraints.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
| FG001 | Placebo | placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants signed consent; however, study was terminated prior to randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
| BG001 | Placebo | placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours. | Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours | Participants signed consent; however, study was terminated prior to randomization | Posted | 48 hours |
|
Not applicable/study was terminated prior to randomization.
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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 | Atorvastatin | atorvastatin: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
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Study Sponsor no longer supplied study drug/placebo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mazen Abu-Fadel, MD | University of Oklahoma | 405-271-4742 | mazen-abufadel@ouhsc.edu |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| atorvastatin | Drug | pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) |
|
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | placebo: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) | 0 | 0 | 0 | 0 |
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| D052801 | Male Urogenital Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |