Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

This study has been terminated.

(The study was terminated because not enough subjects could be recruited.)

Sponsor:

Collaborator:

Merck

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00588471

First received: December 22, 2007

Last updated: October 9, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2007

Last Updated Date

October 9, 2012

Start Date ^ICMJE

November 2002

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Serum High Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: baseline, within 24 hours post percutaneous coronary intervention ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

To determine if one dose of simvastatin will decrease the inflammatory response to coronary intervention. [ Time Frame: 12-24 hours post percutaneous coronary intervention ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00588471 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI [ Time Frame: baseline, within 24 hours post percutaneous coronary intervention ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Determine if one dose of simvastatin affects endothelial function as measured by noninvasive peripheral tonography [ Time Frame: studied prior to drug and agan after angiogram ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

Official Title ^ICMJE

The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Drug: Simvastatin
Placebo Comparator: Placebo
Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00588471

Other Study ID Numbers ^ICMJE

2026-02

Has Data Monitoring Committee

Responsible Party

Amir Lerman, M.D., Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Amir Lerman, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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