Statin and Post-interventional Coronary Microcirculation Dysfunction

Samsung Medical Center

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT01751295

2012-08-052

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

84 participants in 2 patient groups

atorvastatin

Active Comparator group

Description:

PCI with atorvastatin pre-treatment group

Treatment:

Drug: Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI

control

No Intervention group

Description:

PCI without atorvastatin pre-treatment group