Rosuvastatin and Ischemia Reperfusion

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315510
• Other study ID #: QPhT05_131005-Rosuvastatine
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2006
• Last updated: September 22, 2008
• Start date: April 2006
• Est. completion date: August 2007

Study information

• Verified date: September 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers (18-50 years of age)

Exclusion Criteria:

• Hypercholesterolemia

• Hypertension

Study Design

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

Related Conditions & MeSH terms

• Ischemia

Intervention

Drug:
• Rosuvastatin

Locations

Country	Name	City	State
Netherlands	Clinical Research Centre Nijmegen; Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	annexin A5 targeting to ischemically exercised hand
Secondary	plasma lipid levels