Trial | NCT00441597  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Feb 28
2007
Primary Completion
Feb 28
2009
Study Completion
Mar 31
2009
Last Update
Mar 17
2009
Estimate

Drug atorvastatin

atorvastatine 80mg, during 3 days

  • Other names: lipitor

1 Active Comparator

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

2 Active Comparator

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

3 No Intervention

3 days treatment with placebo twice

Criteria 

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
No Results Posted