Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?

Phase 4

Completed

• Conditions: Ischemia Reperfusion Injury
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00457652
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Detailed Description

Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.

Study Timeline

• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-06
• Study Start: 2007-06
• Primary Completion: 2007-09
• Study Completion: 2007-11
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-14
• Last Update Posted: 2008-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Male
• age between 18-50 yrs
• signed informed consent

Exclusion Criteria

• Cardiovascular disease
• Hypertension (systole > 140 mmHg, diastole > 90 mmHg)
• Hypercholesterolemia (fasting total cholesterol > 6,0 mmol/l)
• Drug abuse
• Concomitant medication use
• Inability to perform the ischemic isometric muscle contraction
• Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
• Alanine-Amino-Transferase (ALAT) >90U/L (more than twice the upper level of the normal range)
• Creatinine Kinase (CK) >340U/L (more than twice the upper level of the normal range)
• Participation in any trial concerning medicinal products during the last 60 days prior to this study.
• Participation in clinical trial involving

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	7 day treatment rosuvastatin
2	Rosuvastatin	7 day treatment placebo

Primary Outcome Measures

Name	Time	Method
The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.	60 and 240 minutes after ischemic exercise

Secondary Outcome Measures

Name	Time	Method
Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)	during 10 minutes of ischemic exercise
The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.	before and after 7day treatment
The caffeine serum concentration after 24 hour abstinence .	morning after 24 hours abstinence of caffeine

Trial Locations

Locations (1)

UMCN st.Radboud; 🇳🇱 Nijmegen, Netherlands