Rosuvastatin and Ischemia Reperfusion

This study has been completed.

Sponsor:

Information provided by:

Radboud University

ClinicalTrials.gov Identifier:

NCT00315510

First received: April 14, 2006

Last updated: September 22, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 14, 2006

Last Updated Date

September 22, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

annexin A5 targeting to ischemically exercised hand

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00315510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

plasma lipid levels

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rosuvastatin and Ischemia Reperfusion

Official Title ^ICMJE

Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Ischemia

Intervention ^ICMJE

Drug: Rosuvastatin

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers (18-50 years of age)

Exclusion Criteria:

Hypercholesterolemia
Hypertension

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00315510

Other Study ID Numbers ^ICMJE

QPhT05_131005-Rosuvastatine

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Radboud University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gerard A. Rongen, MD, PhD

Dept. of Pharmacology-Toxicology; Radboud University Medical Centre

Information Provided By

Radboud University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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