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

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NCT00441597

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Study Location
Radboud University Nijmegen Medical Centre
Nijmegen, , 6500 HB, Netherlands
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ischemia Reperfusion Injury, Cardiovascular Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male

- Age 18-50 years

- Informed consent

- Physical able to perform ischemic exercise

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Ischemia Reperfusion Injury, Cardiovascular DiseaseDoes Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
NCT00441597
  1. Nijmegen,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
Official Title  ICMJE Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemia Reperfusion Injury
  • Cardiovascular Disease
Intervention  ICMJE Drug: atorvastatin
atorvastatine 80mg, during 3 days
Other Name: lipitor
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)		30
Original Enrollment  ICMJE
 (submitted: February 28, 2007)		12
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00441597
Other Study ID Numbers  ICMJE atorv01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party G Rongen, dept Pharmacology Toxicology UMCN
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Gerard Rongen, MD PhDRUMCN
PRS Account Radboud University
Verification Date March 2009

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