Rosuvastatin and Ischemia Reperfusion

Phase 2

Completed

• Conditions: Ischemia

• Registration Number: NCT00315510
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Study Completion: 2007-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-22
• Last Update Posted: 2008-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy volunteers (18-50 years of age)

Exclusion Criteria

• Hypercholesterolemia
• Hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
annexin A5 targeting to ischemically exercised hand

Secondary Outcome Measures

Name	Time	Method
plasma lipid levels

Trial Locations

Locations (1)

Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands