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Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588471
First received: December 22, 2007
Last updated: April 12, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
 Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: November 2002
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients scheduled for an angiogram are randomized to receive either Simvastatin or placebo at least 2 hours prior to procedure.
 Drug: Simvastatin
80 mg (2 pills) taken prior to angiogram to determine if it affects the amount of inflammation that typically occurs with percutaneous coronary intervention
Placebo Comparator: 2
patients are randomized to either simvastatin or placebo prior to angiogram
 Drug: Simvastatin
80 mg (2 pills) taken prior to angiogram to determine if it affects the amount of inflammation that typically occurs with percutaneous coronary intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 MI
  • 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> 1qt grapefruit juice/day or nefazodone
  • Patients with creatinine > 2.0
  • Patients with known malignancy
  • EF < 25%
  • No CCU patients
  • No outpatients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588471

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Merck
Investigators
Principal Investigator: Amir Lerman, MD Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amir Lerman, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588471     History of Changes
Other Study ID Numbers: 2026-02
Study First Received: December 22, 2007
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Simvastatin
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 17, 2012