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

Primary Purpose

Ischemia Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia Reperfusion Injury focused on measuring Rosuvastatin, Caffeine, Ischemia, Reperfusion

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • UMCN st.Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

7 day treatment rosuvastatin

7 day treatment placebo

Outcomes

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.

Secondary Outcome Measures

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 .

Full Information

First Posted
April 4, 2007
Last Updated
April 14, 2008
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00457652
Brief Title
Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Official Title
Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia Reperfusion Injury
Keywords
Rosuvastatin, Caffeine, Ischemia, Reperfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
7 day treatment rosuvastatin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
7 day treatment placebo
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
7 day treatment rosuvastatin 20mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)
Time Frame
during 10 minutes of ischemic exercise
Title
The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.
Time Frame
before and after 7day treatment
Title
The caffeine serum concentration after 24 hour abstinence .
Time Frame
morning after 24 hours abstinence of caffeine

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Rongen, MD, Phd
Organizational Affiliation
UMCN st. Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMCN st.Radboud
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15623546
Citation
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.
Results Reference
background
PubMed Identifier
19359665
Citation
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.
Results Reference
derived

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

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