CClinicalTrials.gg
CompletedNCT00441597Updated Mar 17, 2009

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

A Phase 4 interventional study of atorvastatin in Ischemia Reperfusion Injury and Cardiovascular Disease, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-17.

Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.

Read the 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.

02

Conditions studied

  • Ischemia Reperfusion Injury
  • Cardiovascular Disease

Keywords

  • ischemia reperfusion injury
  • atorvastatine
  • preconditioning
  • cardiovascular disease
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    1

    first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg

    Drug: atorvastatin

  • Active comparator
    2

    first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo

    Drug: atorvastatin

  • No intervention
    3

    3 days treatment with placebo twice

Interventions

  • Drugatorvastatin

    atorvastatine 80mg, during 3 days

    Also known as: lipitor

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. workload during ischemic exercise

    Time frame: workload during 10minutes of ischemic exercise

  2. 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

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    Nijmegen, 6500 HB, Netherlands
08

References and documents

Publications

  • 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. PubMed 15623546 ↗
  • Riksen NP, Smits P, Rongen GA. Ischaemic preconditioning: from molecular characterisation to clinical application--part II. Neth J Med. 2004 Dec;62(11):409-23. PubMed 15685892 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00441597
Lead sponsor
Radboud University Medical Center
Collaborators
Pfizer
First posted
Mar 1, 2007
Start date
Feb 2007
Primary completion
Feb 2009
Completion
Mar 2009
Last update
Mar 17, 2009

Study contacts

Gerard Rongen, MD PhD
principal investigator · RUMCN

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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