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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01314235
Other study ID # Clonidinstudy
Secondary ID
Status Recruiting
Phase N/A
First received March 8, 2011
Last updated March 11, 2011
Start date October 2010

Study information

Verified date March 2011
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Clonidin works as a presynaptic agonist of alpha-sympathomimetic receptors of the brain but also in many other tissues. It is part of balanced anesthesia in general anesthesiology as well as a sedastive agent in intensive care units, but also serves as a third-line agent in many psychiatric diseases including ADHD, schizophrenia and PTSD.

The investigators want to show whether clonidin has an procoagulatoric effect on thrombozytes of patients under double anticoagulaotirc treatment with ASS and clopidogrel. The investigators will use a flowcytometric assay to determine activation of thrombozytes when they come into contact with clonidine in vitro as well as Multiplate analyses to determine activation of thrombozytes, either thrombin.induced aggregation, ADP-induced aggregation or arachidonic acid-induced aggregation of thrombozytes.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel

- Age above 18 years

Exclusion Criteria:

- Additional anticoagulatoric treatment woth another inhibitor of platelet aggregation

- Surgery within the last two weeks

- Patients with long-term mediaction with omeprazole

- Patients under hemodialysis

- Patients with renal insufficiency (creatinine above 1.5mg/dl, urea above 80mg/dl)

- Patients with hepatic dysfunction (GOT above 30U/I, GPT above 30 U/I, GLDH above 10 U/I)

- Age under 18 yeary

- Non-responder to ASS and / or clopidogrel

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Johann-Wolfgang-Goethe University Frankfurt Hesse

Sponsors (1)

Lead Sponsor Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numbers of participants with an activated area under the curve in ASPI test Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in ASPI test, i.e. an activated area under the curve in Multiplate analysis. 30 minutes No
Secondary Numbers of participants with an activated area under the curve in TRAP test and ADP test Blood of patients under ASS and clopidogrel will show an activated platelet aggregation due to titrated clonidine in TRAP test and ADP test, i.e. an activated area under the curve in Multiplate analysis. 30 minutes No
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