Does atorvastatin have an acute and prolonged inhibitory effect on ischemia-reperfusion injury in humans in-vivo?

Phase 1

• Conditions: ischemia-reperfusion injury; MedDRA version: 9.1Level: LLTClassification code 10023033Term: Ischemia myocardial

• Registration Number: EUCTR2007-005789-11-NL
• Lead Sponsor: RUNMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-17
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

-Male
-Age 18-50 years
-Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 > 5.0 mmol/l or random total cholesterol >6.5mmol/l)
-Alanine-Amino-Transferase (ALAT) >90 U/L (more than twice the upper level of the normal range)
-Creatinine Kinase (CK) >440 U/L (more than twice the upper level of the normal range)
-Glomerular filtration rate <60ml/min/1.72m2 (assessed using MDRD calculation using gender, age and serum creatinine level)
-Overt clinical signs of hypothyreoidy
-Concomitant chronic use of medication
-Administration of radioactivity for research purposes 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting (acute and prolonged) after ischemic exercise in the non-dominant forearm. This to confirm results from our previous study (CMO 2006/274, ABR NL15624.091.06);Secondary Objective: workload during ischemic exercise, effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels;Primary end point(s): Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion.