Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment atorvastatin, pre-treatment 80 mg/day for 4 days before pci
Sponsor Samsung Medical Center
Start date December 2012
End date August 2014
Trial size 84 participants
Trial identifier NCT01751295, 2012-08-052

Summary

The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
PCI with atorvastatin pre-treatment group
atorvastatin, pre-treatment 80 mg/day for 4 days before pci lipinon
(No Intervention)
PCI without atorvastatin pre-treatment group

Primary Outcomes

Measure
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
time frame: within 1 year after PCI

Secondary Outcomes

Measure
Post-procedural troponin I
time frame: within 1 year after PCI
Post-procedural FFR
time frame: within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel
time frame: within 1 year after PCI

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

Inclusion Criteria: - A. Finished informed consent - B. Stable angina with clinical indication of coronary angiography - C. Age ≥ 21 year and ≤ 80 year Exclusion Criteria: - A.Without informed consent - B.PCI target lesion is not adequate or not indicated for FFR/IMR study - C.Prior myocardial infarction or interventional procedure for PCI target vessel - D.Myocardial infarction within 30 days - E.Usage of statin, current or within 1 month - F.Prior bypass surgery - G.Impaired renal function (Creatinine > 2.0 mg/dL) - H.Impaired left ventricular function (ejection fraction < 40%) - I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN) - J.Contraindication for long-term antiplatelet agent or statin - K.Planning or potential of pregnancy - L.Neoplastic disease without evidence of treatment completion - M.Impaired general condition

Additional Information

Official title Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
Description Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet. In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Samsung Medical Center.