Randomized Comparison Multicenter Trial of High Dose Atorvastatin Pre-treatment on Microcirculatory Dysfunction After Drug-ElutIng Stent Implantation in Patients With Acute Coronary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Index of microcirculatory resistance (IMR)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High dose Atorvastatin
Arm of pre-procedural high dose atorvastatin loading
Intervention: Pre-procedural High dose atorvastatin loading (Drug)
Control
No pre-procedural high dose atorvastatin loading
Intervention: No pre-procedural high-dose atorvastatin loading (Drug)
Outcomes
Primary Outcomes
Index of microcirculatory resistance (IMR)
Time Frame: Immediately after percutaneous coronary intervention
After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.
Secondary Outcomes
- Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure(1 year after index procedure)
Investigators
Bong-Ki Lee
Assistance Professor of Medicine, Kangwon National University School of Medicine
The Korean Society of Circulation