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This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.
This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin 20 mg | Active Comparator | atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery |
|
| Atorvastatin 80 mg | Experimental | atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20 mg | Drug |
|
| |
| Atorvastatin 80 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of atrial fibrillation by hospital discharge | Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings. | Hospital discharge, an expected 5-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Hospital discharge, an expected 5-7 days | |
| Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Nubel | Contact | 402-280-4032 | carolinenubel@creighton.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aiman Smer, MBBCh | Creighton University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University | Recruiting | Omaha | Nebraska | 68131 | United States |
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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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| Drug |
|
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |