Does atorvastatin reduce ischemia-reperfusion injury in humans in-vivo? - ator

Phase 1

• Conditions: ischemia reperfusion injury; MedDRA version: 8.1Level: LLTClassification code 10028596Term: Myocardial infarction

• Registration Number: EUCTR2006-006706-29-NL
• Lead Sponsor: MCN department Pharm-Tox

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-22
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

-Male
-Age 18-50 years
-Informed consent
-Physical able to perform ischemic exercise

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 > 5.5 mmol/l)
- Alanine-Amino-Transferase (ALAT) >90 U/L (more than twice the upper level of the normal range)
- Creatinine Kinase (CK) >340 U/L (more than twice the upper level of the normal range)
- Drug abuse
- Concomitant 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

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 after ischemic exercise in the non-dominant forearm.;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