Does caffeine reduce rosuvastatin-induced protection against ischemia-reperfusion injury? - rosucof

Phase 1

• Conditions: Rosuvastatin is a proven cholesterol lowering medicine. Apart from it’s cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5’-nucleotidase and thereby increasing adenosine activity.This protective effect of rosuvastatin can be abbrogated by using the adenosine receptor antagonist caffeine.; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction; MedDRA version: 9.1Level: LLTClassification code 10023033Term: Ischemia myocardial

• Registration Number: EUCTR2007-000151-33-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-02
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

-Male
-age between 18-50 yrs
-signed 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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Cardiovascular disease
-Hypertension (systole > 140 mmHg, diastole > 90 mmHg)
-Hypercholesterolemia (fasting total cholesterol > 6,0 mmol/l)
-Drug abuse
-Concomittant medication use
-Inability to perform the ischemic isometric muscle contraction
-Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
-Alanine-Amino-Transferase (ALAT) >90U/L (more than twice the upper level of the normal
range)
-Creatinine Kinase (CK) >340U/L (more than twice the upper level of the normal range)
-Participation in any trial concerning medicinal products
during the last 60 days prior to this study.
-Participation in clinical trial involving administration of radioactivity more than 5mSv, during the 5 years prior to this study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this project is to explore the role of adenosine receptor stimulation in the protective effect of rosuvastatin against ischemia-reperfusion injury after ischemic exercise of the forearm.;Secondary Objective: Workload (Half of the maximum forearm force multiplied with the duration of the ischemic exercise). The effect of one-week treatment of rosuvastatine 20mg once daily on lipid spectrum. The caffeine serum concentration after 24 hour abstinence and after infusion of caffeine 4mg/kg or placebo.;Primary end point(s): Annexin A5 targeting (% difference in radioactivity (counts per pixel) between experimental and control thenar muscle is recorded with a gamma camera as an endpoint measure of ischemia-reperfusion injury.