Status:
COMPLETED
Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury
Lead Sponsor:
Radboud University Medical Center
Conditions:
Ischemia Reperfusion Injury
Endothelial Dysfunction
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Rationale: Apart from their cholesterol lowering effects, statins have cholesterol-independent pleiotropic actions, such as upregulation of 5'-ectonucleotidase and up-regulation of NO-synthase that m...
Eligibility Criteria
Inclusion
- Age 18-50
- Written informed consent
Exclusion
- Smoking
- 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 or random cholesterol \>6.5 mmol/L)
- Alanine amino transferase \>90 U/L
- Creatine kinase \>440 U/L
- Raised rhabdomyolysis risk
- GFR \<60 ml/min
- Overt clinical signs of hypothyroidism
- Myopathy in family history
- Alcohol abuse
- Concomitant chronic use of medication
- Participation to any drug-investigation during the previous 60 days as checked with VIP check.
- Professional athletes
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00987974
Start Date
September 1 2009
End Date
March 1 2010
Last Update
April 28 2010
Active Locations (1)
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1
RUNMC
Nijmegen, Netherlands, 6500HB