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Rosuvastatin and Ischemia Reperfusion

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00315510
Enrollment
20
Registered
2006-04-18
Start date
2006-04-30
Completion date
2007-08-31
Last updated
2008-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia

Keywords

Ischemia-reperfusion, Annexin A5

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.

Interventions

DRUGRosuvastatin

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers (18-50 years of age)

Exclusion criteria

* Hypercholesterolemia * Hypertension

Design outcomes

Primary

MeasureTime frame
annexin A5 targeting to ischemically exercised hand

Secondary

MeasureTime frame
plasma lipid levels

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026