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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Goethe University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Goethe University
ClinicalTrials.gov Identifier:
NCT01314235
First received: March 8, 2011
Last updated: March 11, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition
Anticoagulation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Numbers of participants with an activated area under the curve in ASPI test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Numbers of participants with an activated area under the curve in TRAP test and ADP test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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.


Study Start Date: October 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314235

Locations
Germany
Johann-Wolfgang-Goethe University Recruiting
Frankfurt, Hesse, Germany, 60590
Contact: Philipp Schmidt, M.D.         philipp.schmidt@kgu.de    
Sponsors and Collaborators
Goethe University
  More Information

No publications provided

Responsible Party: Philipp Schmidt, Goethe University
ClinicalTrials.gov Identifier: NCT01314235     History of Changes
Other Study ID Numbers: Clonidinstudy
Study First Received: March 8, 2011
Last Updated: March 11, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Goethe University:
anticoagulation with ASS
anticoagulation with clopidogrel

Additional relevant MeSH terms:
Clonidine
Clopidogrel
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on May 16, 2013