Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

• ClinicalTrials.gov Identifier: NCT00588471
• Recruitment Status: Terminated
• First Posted: January 8, 2008
• Results First Posted: November 8, 2012
• Last Update Posted: November 8, 2012
• Sponsor: Mayo Clinic
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by: Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Simvastatin; Drug: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention.
• Study Start Date: November 2002
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Simvastatin; Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.	Drug: Simvastatin; Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.; Other Name: Zocar
Placebo Comparator: Placebo; Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.	Drug: Placebo; Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Outcome Measures

Primary Outcome Measures :

1. Change in Serum High Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: baseline, within 24 hours post percutaneous coronary intervention ]

   The hsCRP test evaluates vascular inflammation. People with higher hsCRP values have the highest risk of cardiovascular disease, and those with lower values have less of a risk. The American Heart Association and U.S. Centers for Disease Control and Prevention have defined risk groups as follows:

   Low risk: less than 1.0 mg/L Average risk: 1.0 to 3.0 mg/L High risk: above 3.0 mg/L

Secondary Outcome Measures :

1. Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI [ Time Frame: baseline, within 24 hours post percutaneous coronary intervention ]

   The EndoPAT is a noninvasive test that involves putting probes on the index fingers of both hands and evaluating the blood flow to one hand before and after inflating a blood pressure cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will now show no blood flow, while the sensor on the opposite index finger will continue to display your normal blood flow level. After several minutes, the blood pressure cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, however, the blood vessels are unhealthy.

   The results are reported as the "Endoscore" (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Amir Lerman, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Amir Lerman, M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00588471
• Other Study ID Numbers: 2026-02
• First Posted: January 8, 2008
• Results First Posted: November 8, 2012
• Last Update Posted: November 8, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Simvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors