Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

Mayo Clinic

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Drug: Placebo; Drug: Simvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00588471

2026-02

Details and patient eligibility

About

The goal of this study is to determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. Also to determine if one dose of simvastatin affects endothelial function (activity of the artery) as measured by noninvasive peripheral artery tonography.

Full description

The objective of this study is to determine if acute pretreatment with simvastatin, an HMG-CoA reductase inhibitor will reduce the post inflammatory response after percutaneous coronary interventions (PCI), and/or change endothelial function as assessed by peripheral arterial tomography (PAT). Percutaneous coronary intervention (PCI), commonly known as coronary angioplasty or simply angioplasty, is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease.

Patients will be pretreated with simvastatin 80 mg prior to undergoing PCI. Endothelial function will be assessed before and after treatment via PAT. Our working hypothesis is patients pretreated with simvastatin, will have 1) attenuated inflammatory response, as noted by decreased levels of serum high sensitivity CRP and IL-6 and 2) improved endothelial function as compared to patients not pretreated with statin therapy.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing PCI/angiography
• No previously known side effects of statins
• Patients who sign an informed consent
• Age > 18 years old

Exclusion criteria

• Patients with ST elevation myocardial infarction
• Patients with cardiogenic shock
• Patients with hypersensitivity to statins
• Patients with unexplained muscle pain
• Patients with acute liver disease
• Patients receiving cyclosporine, antifungal azoles, macrolide antibiotics, niacin, fibrates> 1 quart grapefruit juice/day or nefazodone
• Patients with creatinine > 2.0
• Patients with known malignancy
• Ejection Fraction < 25%
• No coronary care unit patients
• No outpatients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Simvastatin

Active Comparator group

Description:

Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.

Treatment:

Drug: Simvastatin

Placebo

Placebo Comparator group

Description:

Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Treatment:

Drug: Placebo