Rosuvastatin and Ischemia Reperfusion
Information source: Radboud University
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
Gerard A. Rongen, MD, PhD, Principal Investigator, Affiliation: Dept. of Pharmacology-Toxicology; Radboud University Medical Centre
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.
Clinical Details
Official title: Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: annexin A5 targeting to ischemically exercised hand
Secondary outcome: plasma lipid levels
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy volunteers (18-50 years of age)
Exclusion Criteria:
- Hypercholesterolemia
- Hypertension
Locations and Contacts
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland 6500 HB, Netherlands
Additional Information
Related publications: Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. Epub 2004 Dec 27.
Starting date: April 2006
Ending date: August 2006
Last updated: April 4, 2007
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