Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Information source: Radboud University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemia Reperfusion Injury
Intervention: Rosuvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
Gerard Rongen, MD, Phd, Principal Investigator, Affiliation: UMCN st. Radboud
Summary
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?
Clinical Details
Official title: Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.
Secondary outcome: Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum. The caffeine serum concentration after 24 hour abstinence .
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
UMCN st.Radboud, Nijmegen, Netherlands
Additional Information
Related 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.
Starting date: June 2007
Ending date: November 2007
Last updated: April 14, 2008
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