Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?

March 16, 2009 updated by: Radboud University Medical Center
To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent.

Study Type

Interventional

Enrollment (Anticipated)

30

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

  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Age 18-50 years
  • Informed consent
  • Physical able to perform ischemic exercise

Exclusion Criteria:

  • History of any cardiovascular disease
  • Hypertension (in supine position: systole > 140 mmHg, diastole > 90 mmHg)
  • Diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
  • Hyperlipidaemia (fasting total cholesterol > 5.5 mmol/l)
  • Alanine-Amino-Transferase (ALAT) >90 U/L
  • Creatinine Kinase (CK) >440 U/L
  • Drug or alcohol abuse
  • Concommitant chronic use of medication
  • Administration of radioactivity in research setting during the last 5 years
  • Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg
Drug: atorvastatin
atorvastatine 80mg, during 3 days
Other Names:
  • lipitor
Active Comparator: 2
first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo
Drug: atorvastatin
atorvastatine 80mg, during 3 days
Other Names:
  • lipitor
No Intervention: 3
3 days treatment with placebo twice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
Time Frame: 60 and 240 minutes after ischemic exercise
60 and 240 minutes after ischemic exercise

Secondary Outcome Measures

Outcome Measure
Time Frame
workload during ischemic exercise
Time Frame: workload during 10minutes of ischemic exercise
workload during 10minutes of ischemic exercise
effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels
Time Frame: fasting lipid levels before and at first day after 3 day treatment with atorvastatin
fasting lipid levels before and at first day after 3 day treatment with atorvastatin

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

Pfizer

Investigators

  • Principal Investigator: Gerard Rongen, MD PhD, RUMCN

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

February 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2009

Last Update Submitted That Met QC Criteria

March 16, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • atorv01

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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