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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00441597
First received: February 28, 2007
Last updated: March 16, 2009
Last verified: March 2009

February 28, 2007
March 16, 2009
February 2007
February 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
Complete list of historical versions of study NCT00441597 on ClinicalTrials.gov Archive Site
  • workload during ischemic exercise [ Time Frame: workload during 10minutes of ischemic exercise ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • workload during ischemic exercise
  • effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels
Not Provided
Not Provided
 
Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ischemia Reperfusion Injury
  • Cardiovascular Disease
Drug: atorvastatin
atorvastatine 80mg, during 3 days
Other Name: lipitor
  • Active Comparator: 1
    first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg
    Intervention: Drug: atorvastatin
  • Active Comparator: 2
    first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo
    Intervention: Drug: atorvastatin
  • No Intervention: 3
    3 days treatment with placebo twice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2009
February 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00441597
atorv01
No
G Rongen, dept Pharmacology Toxicology UMCN
Radboud University
Pfizer
Principal Investigator: Gerard Rongen, MD PhD RUMCN
Radboud University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP