Randomized Trial of Creatine-kinase Leak After Rosuvastatin At the Time of Percutaneous Coronary Intervention

NCT01968577 | Unknown Phase 4

• 1 other identifier: KBAM-120758
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary angioplasty; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Any creatine kinase elevation

  After 12 hours to hospital discharge

Other Outcomes (1)

• Hospital mortality

  After 12 hours to hospital discharge

Study Arms (2)

Rosuvastatin 40 mg

EXPERIMENTAL

Administration of rosuvastatin 40 mg 2 to 6 hours before percutaneous coronary intervention

Drug: Rosuvastatin

Control group

NO INTERVENTION

The group of patients that do not receive rosuvastatin, 40 mg, before percutaneous coronary intervention.

Interventions

Rosuvastatin DRUG

Rosuvastatin 40 mg before percutaneous coronary intervention

Also known as: Crestor

Rosuvastatin 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kleber Bomfim Araujo Martins: lead

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-180, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kleber B A Martins, MD

  Instituto Dante Pazzanese e Cardiologia e Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keber B A Martins, MD

CONTACT

55 79 8102-9611; klebermartins@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctorate in progress

Study Record Dates

• First Submitted: October 19, 2013
• First Posted: October 24, 2013
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

BR (1)