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

April 14, 2008 updated by: Radboud University Medical Center
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
60 and 240 minutes after ischemic exercise

Secondary Outcome Measures

Outcome Measure
Time Frame
Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)
Time Frame: during 10 minutes of ischemic exercise
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
before and after 7day treatment
The caffeine serum concentration after 24 hour abstinence .
Time Frame: morning after 24 hours abstinence of caffeine
morning after 24 hours abstinence of caffeine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Gerard Rongen, MD, Phd, UMCN St. Radboud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 14, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rosuva01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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