Trial | NCT01491256  Report issue

Title

Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading
Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    100
Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.
One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12~24 hours after PCI.
Study Started
Feb 28
2010
Primary Completion
Nov 30
2011
Study Completion
Feb 29
2012
Anticipated
Last Update
Dec 13
2011
Estimate

Drug Pre-procedural High dose atorvastatin loading

Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention

  • Other names: Lipitor (Pfizer)

Drug No pre-procedural high-dose atorvastatin loading

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

  • Other names: Lipitor (Pfizer)

High dose Atorvastatin Active Comparator

Arm of pre-procedural high dose atorvastatin loading

Control Placebo Comparator

No pre-procedural high dose atorvastatin loading

Criteria 

Inclusion Criteria:

Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention

Exclusion Criteria:

ST elevation myocardial infarction
Cardiogenic shock
Congestive heart failure with pulmonary edema
Severe left ventricular dysfunction (LVEF < 30%)
History of previous coronary revascularization therapy
chronic total coronary occlusion
3 vessel disease
Target lesion at distal segments or branches
Ostial lesion
Excessive coronary calcification or thrombi
Elevated transaminase
Renal dysfunction (serum creatinine > 2.0mg/dL
History of myopathy
Contra-indication to anti-platelet therapy
Not indicated for percutaneous coronary intervention
Other co-morbidity with life expectancy less than 1 year
No Results Posted