Clinical trial NCT00588471: Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention
Official title: The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Serum High Sensitivity C-Reactive Protein (hsCRP)
timeFrame: baseline, within 24 hours post percutaneous coronary intervention
Secondary outcomes:
measure: Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI
timeFrame: baseline, within 24 hours post percutaneous coronary intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References: