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
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|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|
- annexin A5 targeting to ischemically exercised hand
- plasma lipid levels
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
|Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Gerard A. Rongen, MD, PhD||Dept. of Pharmacology-Toxicology; Radboud University Medical Centre|