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

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. Identifier: NCT00441597
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : March 17, 2009
Information provided by:
Radboud University

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

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Cardiovascular Disease Drug: atorvastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
Study Start Date : February 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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 Name: 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 Name: lipitor

No Intervention: 3
3 days treatment with placebo twice

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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

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

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 identifier (NCT number): NCT00441597

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Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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Principal Investigator: Gerard Rongen, MD PhD RUMCN

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Responsible Party: G Rongen, dept Pharmacology Toxicology UMCN Identifier: NCT00441597    
Other Study ID Numbers: atorv01
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009
Keywords provided by Radboud University:
ischemia reperfusion injury
cardiovascular disease
Additional relevant MeSH terms:
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Reperfusion Injury
Wounds and Injuries
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Postoperative Complications
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors