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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457652
First Posted: April 6, 2007
Last Update Posted: April 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  Purpose
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Condition Intervention Phase
Ischemia Reperfusion Injury Drug: Rosuvastatin Phase 4

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Enrollment: 24
Study Start Date: June 2007
Study Completion Date: November 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: April 4, 2007
First Posted: April 6, 2007
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents