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

Purpose

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	Intervention	Phase
Ischemia	Drug: Rosuvastatin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Does Rosuvastatin Reduce Ischemia/Reperfusion Injury in Humans In-Vivo? A Randomized Double Blind Placebo Controlled Trial

Resource links provided by NLM:

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

annexin A5 targeting to ischemically exercised hand

Secondary Outcome Measures:

plasma lipid levels


Estimated Enrollment:	20
Study Start Date:	April 2006
Study Completion Date:	August 2007

Eligibility


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers (18-50 years of age)

Exclusion Criteria:

Hypercholesterolemia
Hypertension

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315510

Locations


Netherlands
Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

Investigators


Principal Investigator:	Gerard A. Rongen, MD, PhD	Dept. of Pharmacology-Toxicology; Radboud University Medical Centre

More Information

Publications:

Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. Epub 2004 Dec 27.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.


ClinicalTrials.gov Identifier:	NCT00315510 History of Changes
Other Study ID Numbers:	QPhT05_131005-Rosuvastatine
Study First Received:	April 14, 2006
Last Updated:	September 22, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:


Ischemia-reperfusion Annexin A5

Additional relevant MeSH terms:


Ischemia Pathologic Processes Rosuvastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors	Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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