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

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ClinicalTrials.gov Identifier: NCT00457652
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : April 15, 2008
Sponsor:
Information provided by:
Radboud University

Brief Summary:
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Drug: Rosuvastatin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Study Start Date : June 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
7 day treatment rosuvastatin
Drug: Rosuvastatin
7 day treatment rosuvastatin 20mg
Placebo Comparator: 2
7 day treatment placebo
Drug: Rosuvastatin
7 day treatment rosuvastatin 20mg



Primary Outcome Measures :
  1. The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage. [ Time Frame: 60 and 240 minutes after ischemic exercise ]

Secondary Outcome Measures :
  1. Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise) [ Time Frame: during 10 minutes of ischemic exercise ]
  2. The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum. [ Time Frame: before and after 7day treatment ]
  3. The caffeine serum concentration after 24 hour abstinence . [ Time Frame: morning after 24 hours abstinence of caffeine ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457652


Locations
Netherlands
UMCN st.Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Gerard Rongen, MD, Phd UMCN st. Radboud

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G Rongen, dept Pharmacology toxicology UMCN
ClinicalTrials.gov Identifier: NCT00457652     History of Changes
Other Study ID Numbers: Rosuva01
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Radboud University:
Rosuvastatin
Caffeine
Ischemia
Reperfusion

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Rosuvastatin Calcium
Caffeine
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents