E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023033 |
E.1.2 | Term | Ischemia myocardial |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male -age between 18-50 yrs -signed informed consent
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |