NCT01264640

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

December 22, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

December 21, 2010

Last Update Submit

December 21, 2010

Conditions

Keywords

Brain-derived neurotrophic factor (BDNF)PlateletsAspirinClopidogrel

Outcome Measures

Primary Outcomes (1)

  • BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake

    24 hours

Secondary Outcomes (1)

  • 5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake

    24 hours

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

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).

A

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50 years
  • Gender: Male

You may not qualify if:

  • Any acute disease
  • Any chronic disease
  • Any medication
  • Allergies / Intolerance in association with Aspirin or Clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Pneumology, University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related 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. doi: 10.1016/j.neurobiolaging.2004.03.002.

    PMID: 15585351BACKGROUND

Related Links

MeSH Terms

Interventions

AspirinClopidogrel

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marek Lommatzsch, PD Dr.

    University of Rostock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

December 22, 2010

Record last verified: 2010-07

Locations