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| Name | Class |
|---|---|
| West Penn Allegheny Health System | OTHER |
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This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin calcium | Active Comparator | Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery |
|
| Sugar Pill | Placebo Comparator | Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin calcium | Drug | Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention. | 15 and 30 days post revascularization |
| Measure | Description | Time Frame |
|---|---|---|
| Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention. | 15 and 30 days post revascularization | |
| Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venkatraman Srinivasan, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States | ||
| The Western Pennsylvania Hospital |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Inactive Placebo | Drug | Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery. |
|
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| 15 and 30 days post revascularization |
| Symptomatic side effects of current statin medication as described by adverse effects on consent form. | Immediately post revascularization to 30 days. |
| Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA) | 15 and 30 days post revascularization |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002241 | Carbohydrates |