Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention (CLEAR-PCI)
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|ClinicalTrials.gov Identifier: NCT01968577|
Recruitment Status : Unknown
Verified October 2013 by Kleber Bomfim Araujo Martins, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : October 24, 2013
Last Update Posted : October 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Rosuvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: Rosuvastatin 40 mg
Administration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention
Rosuvastatin 40 mg before percutaneous coronary intervention
Other Name: Crestor
No Intervention: Control group
The group of patients that do not receive rosuvastatin, 40 mg, before percutaneous coronary intervention.
- Periprocedural myocardial infarction (Myocardial enzymes arise) [ Time Frame: After 12 hours to hospital discharge ]Myocardial enzyme arise 3 times of upper limit of normal, 12 hours of the percutaneous coronary intervention until peak value at hospital discharge.
- Any creatine kinase elevation [ Time Frame: After 12 hours to hospital discharge ]Any myocardial enzyme arise after 12 hours of the percutaneous coronary intervention until peak value at hospital discharge.
- Hospital mortality [ Time Frame: After 12 hours to hospital discharge ]All cause of mortality at the time of the percutaneous coronary intervention to hospital discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968577
|Contact: Keber B A Martins, MD||55 79 email@example.com|
|Instituto Dante Pazzanese de Cardiologia||Recruiting|
|Sao Paulo, Brazil, 04012-180|
|Contact: AMANDA S GUERRA, DIRECTOR 55-11-5085-6000 firstname.lastname@example.org|
|Principal Investigator: KLEBER B A MARTINS, MD|
|Principal Investigator:||Kleber B A Martins, MD||Instituto Dante Pazzanese e Cardiologia e Sao Paulo|