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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by University of Rostock.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264640
First Posted: December 22, 2010
Last Update Posted: December 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rostock
  Purpose
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 Intervention
Healthy Volunteers Drug: Aspirin and Clopidogrel

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake [ Time Frame: 24 hours ]

Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264640


Locations
Germany
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
  More Information

Additional Information:
Publications:
Responsible Party: PD Dr. Marek Lommatzsch, Abteilung für Pneumologie, University of Rostock
ClinicalTrials.gov Identifier: NCT01264640     History of Changes
Other Study ID Numbers: LO-0005
First Submitted: December 21, 2010
First Posted: December 22, 2010
Last Update Posted: December 22, 2010
Last Verified: July 2010

Keywords provided by University of Rostock:
Brain-derived neurotrophic factor (BDNF)
Platelets
Aspirin
Clopidogrel

Additional relevant MeSH terms:
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors