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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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The purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(MACE).
Background: Strategies to reduce complications in acute coronary syndrome treatment have been largely studied. Due to its pleiotropic effects statins are considered an important tool on atherosclerotic plaque stability. Although, the usage of statins before percutaneous coronary intervention in acute coronary syndrome patients, has not yet been demonstrated. Objectives: Evaluate if a loading dose of atorvastatin (80mg) before percutaneous coronary intervention in acute coronary syndrome patients, followed by a reload dose 24 hours, is able to reduce major cardiovascular events (MACE); including combined outcomes such as all-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting after 30 days. Methods: Multicentric randomised controlled clinical trial, with allocation concealment and intention to treat analysis. Competitive recruitment will involve 4,192 patients. Acute coronary syndrome patients intending to undergo percutaneous coronary intervention with or without stent placement will be randomized 1:1 to receive either atorvastatin 80mg or placebo before the coronary procedure and also a reload dosage after 24 hours from angioplasty. All patients will collect blood sample to determine CKMB levels pre and post procedure (6 to 12h and 18 to 24 hours). After 30 days, an in person interview will be performed and blood sample will be collected in order to dosage AST, ALT, CPK, and cholesterol levels. Telephonic interview will be done at 6 and 12 months to access occurrence of cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Cardiovascular Events (MACE) | All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major Cardiovascular Events (MACE) | 6 months and 12 months | |
| All-cause mortality | 30 days, 6 months and 12 months | |
| Non-fatal Myocardial Infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otavio Berwanger | Hospital do Coracao | Study Chair |
| Renato D Lopes, MD, PhD | Brazilian Clinical Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Coracao | São Paulo | São Paulo | 04005-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29525821 | Result | Berwanger O, Santucci EV, de Barros E Silva PGM, Jesuino IA, Damiani LP, Barbosa LM, Santos RHN, Laranjeira LN, Egydio FM, Borges de Oliveira JA, Dall Orto FTC, Beraldo de Andrade P, Bienert IRC, Bosso CE, Mangione JA, Polanczyk CA, Sousa AGMR, Kalil RAK, Santos LM, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, Giraldez RRCV, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JEMR, Alexander JH, Granger CB, Lopes RD; SECURE-PCI Investigators. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial. JAMA. 2018 Apr 3;319(13):1331-1340. doi: 10.1001/jama.2018.2444. | |
| 30264159 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular 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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| Placebo | Drug | Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days |
|
| 30 days, 6 months and 12 months |
| Non-fatal Stroke | 30 days, 6 months and 12 months |
| Revascularization | 30 days, 6 months and 12 months |
| Cardiovascular death | 30 days, 6 months and 12 months |
| Stent Thrombosis | 30 days, 6 months and 12 months |
| Target vessel revascularization | 30 days, 6 months and 12 months |
| Rhabdomyolysis | 7 days or at hospital discharge |
| Bleeding episode | 7 days or hospital discharge |
| Derived |
| Lopes RD, de Barros E Silva PGM, de Andrade Jesuino I, Santucci EV, Barbosa LM, Damiani LP, Nakagawa Santos RH, Laranjeira LN, Dall Orto FTC, Beraldo de Andrade P, de Castro Bienert IR, Alexander JH, Granger CB, Berwanger O. Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial. JAMA Cardiol. 2018 Nov 1;3(11):1113-1118. doi: 10.1001/jamacardio.2018.3408. |
| 29653634 | Derived | Berwanger O, de Barros E Silva PGM, Dall Orto FTC, de Andrade PB, de Castro Bienert IR, Bosso CE, Mangione J, Polanczyk CA, Sousa A, Kalil R, de Moura Santos L, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, de Andrade Jesuino I, Santucci EV, Damiani LP, Laranjeira LN, Borges de Oliveira JA, Giraldez RR, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JE, Alexander JH, Granger CB, Lopes RD. Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial. Am Heart J. 2018 Apr;198:129-134. doi: 10.1016/j.ahj.2017.12.018. Epub 2018 Jan 8. |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |