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

NCT ID: NCT00457652

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-11-30

Brief Summary

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Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Detailed Description

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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.

Conditions

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Ischemia Reperfusion Injury

Keywords

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Rosuvastatin Caffeine Ischemia Reperfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

7 day treatment rosuvastatin

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

7 day treatment rosuvastatin 20mg

2

7 day treatment placebo

Group Type PLACEBO_COMPARATOR

Rosuvastatin

Intervention Type DRUG

7 day treatment rosuvastatin 20mg

Interventions

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Rosuvastatin

7 day treatment rosuvastatin 20mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dept Pharmacology toxicology UMCN

Principal Investigators

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Gerard Rongen, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

UMCN st. Radboud

Locations

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UMCN st.Radboud

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.

Reference Type BACKGROUND
PMID: 15623546 (View on PubMed)

Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.

Reference Type DERIVED
PMID: 19359665 (View on PubMed)

Other Identifiers

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Rosuva01

Identifier Type: -

Identifier Source: org_study_id