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Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention (CLEAR-PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Kleber Bomfim Araujo Martins, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Rosuvastatin 40 mg
Administration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention
Drug: Rosuvastatin
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with clinical signs of stable angina (Classification of Canadian Cardiovascular Society 1, 2, 3 or 4) or asymptomatic with evidence of ischemia-induced functional tests with indication of elective PCI.
  • Use of statins for a period equal to or greater than 7 days or reported by the patient and confirmed by medical prescription.
  • Stent implantation in de novo lesions in native coronary arteries were considered eligible for the study
  • The patient or legal representative must sign the consent form before the procedure, in form containing all the details of the research approved by the Ethics Committee of the Institution.

Exclusion Criteria:

  • Women of childbearing potential who are not using appropriate contraceptive measures during pregnancy and lactation .
  • Values above the upper limit of normal serum levels of CK-MB mass harvested 24 hours prior to the procedure.
  • Myocardial infarction < 15 days.
  • Renal insufficiency with creatinine clearance < 30 ml/min
  • Patients with known allergy, hypersensitivity or contraindication to any of the following: aspirin , heparin , clopidogrel , ticagrelor , and statin or iodinated contrast .
  • Participation in other research to influence serum levels of CK-MB mass
  • Have taken fibrate 24 hours before the intervention .
  • Use of oral anticoagulants or glycoprotein inhibitors at the day of the procedure .
  • Evidence of angiographic intracoronary thrombus in the target lesion .
  • In -stent restenosis , vein graft or arterial .
  • Complications of the procedure as irreversible occlusion of the target vessel as well as branch greater than 1mm in diameter , presence of dissection with compromised flow, caging branch with reduced flow , coronary spasm with abnormal blood flow and distal embolization .
  • Inability to deploy stent .
  • Use of atherectomy technique .
  • Patients were randomized to rosuvastatin be administered prior to the procedure , having the guidewire stent reached the ostium of the coronary target with time less than two hours or having exceeded the period of six hours after oral ingestion.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01968577

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Contact: Keber B A Martins, MD 55 79 8102-9611

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Instituto Dante Pazzanese de Cardiologia Recruiting
Sao Paulo, Brazil, 04012-180
Contact: AMANDA S GUERRA, DIRECTOR    55-11-5085-6000   
Principal Investigator: KLEBER B A MARTINS, MD         
Sponsors and Collaborators
Kleber Bomfim Araujo Martins
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Principal Investigator: Kleber B A Martins, MD Instituto Dante Pazzanese e Cardiologia e Sao Paulo
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Responsible Party: Kleber Bomfim Araujo Martins, Doctorate in progress, University of Sao Paulo Identifier: NCT01968577    
Other Study ID Numbers: KBAM-120758
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013
Keywords provided by Kleber Bomfim Araujo Martins, University of Sao Paulo:
Coronary angioplasty
Myocardial infarction
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors