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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Rostock.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT01264640
First received: December 21, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 21, 2010
Last Updated: December 21, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on October 23, 2014