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

• Sponsor: University of Rostock (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01264640
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Aspirin and Clopidogrel	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2011
• Anticipated Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: A Intake of 500 mg Aspirin on day 1. Intake of 600 mg Clopidogrel on day 28. 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).

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).

Outcome Measures

Primary Outcome Measures

1. BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake [24 hours]

Secondary Outcome Measures

1. 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. of Pneumology, University of Rostock	Rostock	Mecklenburg-Vorpommern	Germany	18057

Sponsors and Collaborators

• University of Rostock

Investigators

• Principal Investigator: Marek Lommatzsch, PD Dr., University of Rostock

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the Medical faculty of the University of Rostock

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01264640
• Other Study ID Numbers: LO-0005
• First Posted: Dec 22, 2010
• Last Update Posted: Dec 22, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Brain-derived neurotrophic factor (BDNF); Platelets; Aspirin; Clopidogrel
• Additional relevant MeSH terms: Aspirin; Clopidogrel

Study Results

No Results Posted as of Dec 22, 2010