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Patients with stable coronary disease when undergoing percutaneous coronary intervention may present periprocedural myocardial infarction defined at present as a creatine kinase-myocardial isoenzyme (CK-MB) elevation 3 times upper limit of normal, as a cut off for periprocedural myocardial infarction after PCI. Although percutaneous coronary intervention is associated with low rates of complications, periprocedural myocardial infarction has been touted as a negative factor in long-term clinical results . Several clinical, anatomical and technical associate to the occurrence of this event . Although randomized controlled trials and systematic reviews to statin pre intervention have targeted the administration of high-dose statin is recommended before surgery to reduce the risk of periprocedural myocardial infarction, there is no information on the impact of the maximum concentration plasma of statin at the time of percutaneous coronary intervention in stable patients on chronic statin use in preventing periprocedural myocardial infarction or the elevation of cardiac enzymes . The anti-ischemic effect of statins in percutaneous coronary intervention was mainly determined in statin -naïve patients or in patients with acute coronary syndromes . In this work , we studied the impact of the peak plasma concentration of statin at the time of percutaneous coronary intervention was studied through prospective randomized single center in stable patients with chronic statin divided into two groups . In the group (1) Experimental (n = 268 ) was administered at a dose of 40 mg rosuvastatin between one and six hours before surgery and group (2) control without rosuvastatin (n = 268). This range 1 to 6 hours is the time at the peak concentration of rosuvastatin in the blood after oral ingestion. The primary objective was to assess the incidence of periprocedural myocardial infarction by creatine kinase above three times upper normal limit in hospital period and as a secondary objective to analyze the elevation of any amount of creatine kinase on the baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 40 mg | Experimental | Administration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention |
|
| Control group | No Intervention | The group of patients that do not receive rosuvastatin, 40 mg, before percutaneous coronary intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 40 mg before percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural myocardial infarction (Myocardial enzymes arise) | Myocardial enzyme arise 3 times of upper limit of normal, 12 hours of the percutaneous coronary intervention until peak value at hospital discharge. | After 12 hours to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Any creatine kinase elevation | Any myocardial enzyme arise after 12 hours of the percutaneous coronary intervention until peak value at hospital discharge. | After 12 hours to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital mortality | All cause of mortality at the time of the percutaneous coronary intervention to hospital discharge. | After 12 hours to hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keber B A Martins, MD | Contact | 55 79 8102-9611 | klebermartins@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Kleber B A Martins, MD | Instituto Dante Pazzanese e Cardiologia e Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | Recruiting | São Paulo | São Paulo | 04012-180 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 2, 2014 | |
| Reset | Mar 24, 2014 | |
| Release | Mar 28, 2014 | |
| Reset | Apr 29, 2014 | |
| Release | May 25, 2014 | |
| Reset | Jun 25, 2014 | |
| Release | Jun 28, 2014 | |
| Reset | Jul 30, 2014 | |
| Release | May 15, 2015 | |
| Reset | Jun 1, 2015 | |
| Release | Nov 3, 2015 | |
| Reset | Dec 8, 2015 | |
| Release | Feb 24, 2016 | |
| Reset | Mar 24, 2016 | |
| Release | Apr 12, 2016 | |
| Reset | May 18, 2016 | |
| Release | Jun 5, 2016 | |
| Reset | Jul 13, 2016 | |
| Release | Sep 19, 2016 | |
| Reset | Nov 7, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 2, 2014 | Mar 24, 2014 | |||
| Mar 28, 2014 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Apr 29, 2014 |
| May 25, 2014 | Jun 25, 2014 |
| Jun 28, 2014 | Jul 30, 2014 |
| May 15, 2015 | Jun 1, 2015 |
| Nov 3, 2015 | Dec 8, 2015 |
| Feb 24, 2016 | Mar 24, 2016 |
| Apr 12, 2016 | May 18, 2016 |
| Jun 5, 2016 | Jul 13, 2016 |
| Sep 19, 2016 | Nov 7, 2016 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |