drugset / Trial / NCT00315510

Rosuvastatin and Ischemia Reperfusion

NCT00315510

Phase 2 Completed 20 enrolled Radboud University Medical Center
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-04
Primary completion
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 20 mg

Indications