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

NCT01314235 | Unknown

• 1 other identifier: Clonidinstudy
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anticoagulation

Keywords

anticoagulation with ASS; anticoagulation with clopidogrel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Numbers of participants with an activated area under the curve in TRAP test and ADP test

  30 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients going under vascular surgery with anticagulation with both ASS and clopidogrel

You may qualify if:

• Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
• Age above 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

Johann-Wolfgang-Goethe University

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 14, 2011
• Study Start: October 1, 2010
• Last Updated: March 14, 2011

Record last verified: 2011-03

Locations

DE (1)