Ischemia Clinical Trial
Official title:
Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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