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| Sponsors and Collaborators: |
Mayo Clinic Merck |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00588471 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | The Effect of Acute Statin Treatment on Inflammation and Peripheral Arterial Tone in Patients Undergoing Percutaneous Coronary Intervention. |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
2: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rebecca E. Nelson, CCRC | 507-255-5123 ext 8388 | nelson.rebecca@mayo.edu |
| Contact: Geralyn Pumper, RN | 507-255-5123 ext 9525 | pumper.geralyn@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Rebecca E. Nelson, CCRC 507-255-5123 ext 8388 nelson.rebecca@mayo.edu | |
| Principal Investigator: | Amir Lerman, MD | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( Amir Lerman, M.D. ) |
| Study ID Numbers: | 2026-02 |
| Study First Received: | December 22, 2007 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00588471 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Arterial Occlusive Diseases Antimetabolites Heart Diseases Simvastatin Myocardial Ischemia Antilipemic Agents Vascular Diseases |
Anticholesteremic Agents Ischemia Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Inflammation Coronary Disease Coronary Artery Disease |
|
Arterial Occlusive Diseases Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Anticholesteremic Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |
