Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
NCT00441597
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- Male
- Age 18-50 years
- Informed consent
- Physical able to perform ischemic exercise
- 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
- Creatinine Kinase (CK) >440 U/L
- Drug or alcohol abuse
- Concommitant 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
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Descriptive Information | ||||
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Brief Title ICMJE | Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo? | |||
Official Title ICMJE | Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo? | |||
Brief Summary | To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm. | |||
Detailed Description | 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: atorvastatin
atorvastatine 80mg, during 3 days Other Name: lipitor | |||
Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 30 | |||
Original Enrollment ICMJE | 12 | |||
Actual Study Completion Date ICMJE | March 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00441597 | |||
Other Study ID Numbers ICMJE | atorv01 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | G Rongen, dept Pharmacology Toxicology UMCN | |||
Study Sponsor ICMJE | Radboud University | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Radboud University | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |