Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?

NCT00441597 | Completed Phase 4

• 1 other identifier: atorv01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia Reperfusion Injury; Cardiovascular Disease

Keywords

ischemia reperfusion injury; atorvastatine; preconditioning; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.

  60 and 240 minutes after ischemic exercise

Secondary Outcomes (2)

• workload during ischemic exercise

  workload during 10minutes of ischemic exercise

• effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels

  fasting lipid levels before and at first day after 3 day treatment with atorvastatin

Study Arms (3)

1

ACTIVE COMPARATOR

first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg

Drug: atorvastatin

2

ACTIVE COMPARATOR

first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo

Drug: atorvastatin

3

NO INTERVENTION

3 days treatment with placebo twice

Interventions

atorvastatin DRUG

atorvastatine 80mg, during 3 days

Also known as: lipitor

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (2)

• Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.

  PMID: 15623546 BACKGROUND

• Riksen NP, Smits P, Rongen GA. Ischaemic preconditioning: from molecular characterisation to clinical application--part II. Neth J Med. 2004 Dec;62(11):409-23.

  PMID: 15685892 BACKGROUND

MeSH Terms

Conditions

Reperfusion Injury; Cardiovascular Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Gerard Rongen, MD PhD

  RUMCN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 1, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

NL (1)