Healthy VolunteersNCT01264640
Anti-Platelet Drugs and Brain-derived Neurotrophic Factor (BDNF) in Human Serum and Plasma
A study testing Aspirin and Clopidogrel in people with Healthy Volunteers, run by University of Rostock at 1 site in Germany.
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)… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- Gender: Male
Who cannot join
- Any acute disease
- Any chronic disease
- Any medication
- Allergies / Intolerance in association with Aspirin or Clopidogrel
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. of Pneumology, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma
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.
- Conditions
- Healthy Volunteers
- Being tested
- Aspirin and Clopidogrel
- Keywords
- Brain-derived neurotrophic factor (BDNF), Platelets, Aspirin, Clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and ClopidogrelDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Aspirin and Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake
Measured: 24 hours
Secondary outcomes (1)
5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Investigators
- Marek Lommatzsch, PD Dr., Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264640
- Sponsor's protocol ID
- LO-0005
- Status last verified
- Jul 2010
- First submitted
- 21 Dec 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.neurobiolaging.2004.03.002.
PubMed 15585351
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aspirin and Clopidogrel on Brain-derived Neurotrophic Factor (BDNF) Concentrations in Human Serum and Plasma
- ClinicalTrials.gov ID
- NCT01264640
- Acronym / sponsor ID
- LO-0005
- Conditions
- Healthy Volunteers
- Keywords
- Brain-derived neurotrophic factor (BDNF), Platelets, Aspirin, Clopidogrel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Aspirin and ClopidogrelIntake 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years
- Gender: Male
Key exclusion criteria (4 listed)
- Any acute disease
- Any chronic disease
- Any medication
- Allergies / Intolerance in association with Aspirin or Clopidogrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin and ClopidogrelIntake 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). | Drug | A |
Primary outcome
BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake
Time frame: 24 hours
1 secondary outcome
5-HT and TGF-beta concentrations 24 hours after Aspirin or Clopidgrel intake
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
- Background: PubMed 15585351Lommatzsch 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.
- Website of the Medical faculty of the University of RostockLink provided by the sponsor.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Lommatzsch, PD Dr. principal investigator
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Clopidogrel in people with Healthy Volunteers, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF plasma and serum concentration 24 hours after Aspirin or Clopidgrel intake (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2010.