Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

NCT00588471 | Terminated Results

• 1 other identifier: 2026-02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in Serum High Sensitivity C-Reactive Protein (hsCRP)

  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

  baseline, within 24 hours post percutaneous coronary intervention

Secondary Outcomes (1)

• Change in Endothelial Peripheral Arterial Tomography (EndoPAT) Score After PCI

  baseline, within 24 hours post percutaneous coronary intervention

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

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

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Simvastatin DRUG

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

Also known as: Zocar

Simvastatin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Amir Lerman
• Organization: Mayo Clinic

lerman.amir@mayo.edu

507-255-7760

Study Officials

• Amir Lerman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: November 1, 2002
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 8, 2012
• Results First Posted: November 8, 2012

Record last verified: 2012-10

Locations

US (1)