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NCT01264640 Clinical Trial

Anti-Platelet Drugs and Brain-derived Neurotrophic Factor (BDNF) in Human Serum and Plasma

Healthy Volunteers Clinical Trial

Official title:
The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01264640
Other study ID # LO-0005
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 21, 2010
Last updated December 21, 2010
Start date July 2010
Est. completion date March 2011

Study information
Verified date July 2010
Source University of Rostock
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The impact of anti-platelet drugs on the concentrations of Brain-derived neurotrophic factor (BDNF) in human plasma and serum is unknown. It is the aim of this study to investigate the impact of a single dose of Aspirin (500 mg) or Clopdigrel (600 mg) on the concentrations of Brain-derived neurotrophic factor (BDNF) in plasma and serum of healthy volunteers.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25
Est. completion date March 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Age 18-50 years

- Gender: Male

Exclusion Criteria:

- Any acute disease

- Any chronic disease

- Any medication

- Allergies / Intolerance in association with Aspirin or Clopidogrel

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Aspirin and Clopidogrel
Intake of 500 mg Aspirin on day 1. Intake of 600 mg Clopidogrel on day 28. Blood collection for the measurement of platelet inhibition, platelet counts and BDNF, TGF-beta, 5-HT concentrations in peripheral blood on day 1 (before intake of 500 mg Aspirin), day 2 (24 hours after intake of 500 mg Aspirin), day 28 (before intake of 600 mg Clopidogrel), day 29 (24 hours after intake of 600 mg Clopidogrel).

Locations
Country Name City State
Germany Dep. of Pneumology, University of Rostock Rostock Mecklenburg-Vorpommern

Sponsors (1)
Lead Sponsor Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Lommatzsch M, Zingler D, Schuhbaeck K, Schloetcke K, Zingler C, Schuff-Werner P, Virchow JC. The impact of age, weight and gender on BDNF levels in human platelets and plasma. Neurobiol Aging. 2005 Jan;26(1):115-23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake 24 hours No
Secondary 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake 24 hours No
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