Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1470 |
Not provided
Not provided
Slower than anticipated enrollment for pilot study.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No atorvastatin | No Intervention | Patients do not receive Atorvastatin prior to PCI in cath lab | |
| atorvastatin | Experimental | Atorvastatin 80mg po given prior to PCI in cath lab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin 80mg po given one time before PCI in cath lab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural Myonecrosis | 16-24 hours post PCI |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolf Kreutz, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Wishard Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27350760 | Derived | Kreutz RP, Breall JA, Sinha A, von der Lohe E, Kovacs RJ, Flockhart DA. Simultaneous administration of high-dose atorvastatin and clopidogrel does not interfere with platelet inhibition during percutaneous coronary intervention. Clin Pharmacol. 2016 Jun 3;8:45-50. doi: 10.2147/CPAA.S98790. eCollection 2016. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Atorvastatin | Patients do not receive Atorvastatin prior to PCI in cath lab |
| FG001 | Atorvastatin | Atorvastatin 80mg po given prior to PCI in cath lab Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Atorvastatin | Patients do not receive Atorvastatin prior to PCI in cath lab |
| BG001 | Atorvastatin | Atorvastatin 80mg po given prior to PCI in cath lab Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Periprocedural Myonecrosis | Posted | Number | participants | 16-24 hours post PCI |
|
|
|
|
Not provided
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 | No Atorvastatin | Patients do not receive Atorvastatin prior to PCI in cath lab | 0 | 32 | 0 | 32 | ||
| EG001 | Atorvastatin | Atorvastatin 80mg po given prior to PCI in cath lab Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab. | 0 | 28 | 0 | 28 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rolf Kreutz | Indiana University School of Medicine | 3179620500 | rkreutz@iu.edu |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|