Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01314235
• Other study ID #: Clonidinstudy
• 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
• 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

• Anticoagulation

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