A Phase 4 interventional study of rosuvastatin and atorvastatin 3 days in Ischemia Reperfusion Injury and Endothelial Dysfunction, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-28.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Prevention
Rationale:
Apart from their cholesterol lowering effects, statins have cholesterol-independent pleiotropic actions, such as upregulation of 5'-ectonucleotidase and up-regulation of NO-synthase that may increase tolerance against ischemia-reperfusion injury (IR-injury). Several animal studies have shown reduction of IR-injury as a result of statin treatment in both the heart and the kidney. Recently the investigators have shown, using Annexin A5 targeting after voluntary ischemic exercise to assess IR-injury, a protective effect of a 7 day oral rosuvastatin treatment. A three day treatment with atorvastatin however failed to reduce annexin targeting.
Assessment of the flow mediated dilation of the brachial artery as measure of endothelial (dys)function, is a validated model to research effects of possible protective strategies and perform mechanistic experiments on IR-injury in humans in vivo.
The investigators hypothesize that pretreatment with statins can increase endothelial tolerance against ischemia and reperfusion injury.
Objective:
To study the protective effect of pretreatment (both 3 day and 7 day) with rosuvastatin and atorvastatin on flow mediated dilation after 15 minutes ischemia and 15 minutes reperfusion.
Study design: placebo-controlled randomised double-blind trial
Study population: Healthy volunteers, age 18-50
Intervention: Treatment with either rosuvastatin 20 mg, atorvastatin 80mg or placebo during either 3 or 7 days
Main study parameters: Difference in flow mediated dilation before and after 15 minutes ischemia.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment with rosuvastatin or atorvastatin is not expected to harm the volunteers. Most reported side effects of rosuvastatin and atorvastatin are gastro-intestinal complains and myalgia. The volunteers will not benefit directly from participating in this study.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's planned enrollment of 48 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Raised rhabdomyolysis risk
8 Subjects will use rosuvastatin 20 mg/day for 3 days
Drug: rosuvastatin
8 Subjects will use atorvastatin 80 mg/day for 3 days.pj
Drug: atorvastatin 3 days
8 Subjects will use placebo for 3 days.
Drug: placebo
8 Subjects will use rosuvastatin 20 mg/day for 7 days.
Drug: rosuvastatin 7 days
8 Subjects will use atorvastatin 80 mg/day for 7 days.
Drug: atorvastatin 7 days
8 Subjects will use placebo for 7 days.
Drug: placebo 7 days
rosuvastatin 20 mg/day for 3 days.
Also known as: crestor
atorvastatin 80 mg/day for 3 days.
Also known as: lipitor
placebo for 3 days.
rosuvastatin 20 mg/day for 7 days
Also known as: crestor
atorvastatin 80 mg/day for 7 days.
Also known as: lipitor
placebo 7 days
Difference in flow mediated dilation before and after 15 minutes ischemia
Time frame: 30 minutes
Ecto-5'-nucleotidase activity and lipid profile after statin therapy
Time frame: 3-7 days
This study is completed, as verified in Apr 2001. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center