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High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. |
|
| Placebo | Placebo Comparator | Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 40 mg PO qd x 5 days before surgery and then from post-op day 0 to 5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improved Inflammatory Markers | Significant (p<0.05) improvement of measured inflammatory markers | Within 5 days post-op and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Significant (p<0.05) reduction of mortality in rosuvastatin arm versus placebo | Within 3 months |
| Stroke | Significant (p<0.05) reduction of stroke events in rosuvastatin arm versus placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Genest, MD | RI-MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
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| Placebo | Drug | Placebo 1 tab qd x 5d before operation and then from post-op day 0 to 5. |
|
| Within 3 months |
| Myocardial Infarction | Significant (p<0.05) reduction of MI events in rosuvastatin arm versus | Within 3 months |
| ICU length of stay | Significant reduction (p<0.05) of length of stay in rosuvastatin arm versus placebo | 3 months |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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