Anticoagulation Clinical Trial
Official title:
The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study
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 |
Verified date | March 2011 |
Source | Goethe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Johann-Wolfgang-Goethe University | Frankfurt | Hesse |
Lead Sponsor | Collaborator |
---|---|
Goethe University |
Germany,
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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