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Rosuvastatin and Ischemia Reperfusion

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ClinicalTrials.gov Identifier: NCT00315510
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:
Radboud University

Study Description
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Brief Summary:

Statins, including rosuvastatin, are drugs that lower plasma cholesterol and prevent atherosclerotic disease. Recent preclinical evidence suggests that statins also increase tissue tolerance to ischemia-reperfusion injury.

This is a randomized, double blind, parallel designed study comparing the effect of 1 week treatment with rosuvastatin (20 mg, once a day) with placebo on forearm ischemia-reperfusion injury in healthy male volunteers. Forearm ischemia-reperfusion injury is quantified with Tc-99m-annexin A5 scintigraphy of the hands after a standardized ischemic exercise test. For this purpose, Tc-99m-rh-annexin A5 (400 MBq; < 5 mSv) is injected intravenously upon reperfusion, followed by scintigraphy of both hands with a gamma camera at 1 and 4 hours after injection. Annexin A5 targeting is calculated as the percentage difference in activity (counts/pixel) between the thenar muscles of both hands.


Condition or disease Intervention/treatment Phase
Ischemia Drug: Rosuvastatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
Study Start Date : April 2006
Actual Study Completion Date : August 2007

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. annexin A5 targeting to ischemically exercised hand

Secondary Outcome Measures :
  1. plasma lipid levels

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers (18-50 years of age)

Exclusion Criteria:

  • Hypercholesterolemia
  • Hypertension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315510


Locations
Netherlands
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Gerard A. Rongen, MD, PhD Dept. of Pharmacology-Toxicology; Radboud University Medical Centre
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00315510     History of Changes
Other Study ID Numbers: QPhT05_131005-Rosuvastatine
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by Radboud University:
Ischemia-reperfusion
Annexin A5

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors