AnticoagulationNCT01314235
Influence of Clonidine on Thrombozytes of Blood of Patients Under Anticoagulation Therapy With ASS and Clopidogrel
An observational study of Anticoagulation, run by Goethe University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Oct 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients going under vascular surgery with anticagulation with both ASS and clopidogrel
Who may be able to join
- Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
- Age above 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johann-Wolfgang-Goethe University
Frankfurt am Main, Hesse, 60590
Philipp Schmidt, M.D., philipp.schmidt@kgu.de
About this study
Official title: The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314235
- Sponsor's protocol ID
- Clonidinstudy
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 14 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Clonidine on the Thrombozytes of Patients Under Double Anticagulation With ASS and Clopidogrel - an in Vitro Study
- ClinicalTrials.gov ID
- NCT01314235
- Acronym / sponsor ID
- Clonidinstudy
- Conditions
- Anticoagulation
- Keywords
- anticoagulation with ASS, anticoagulation with clopidogrel
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients going under vascular surgery with anticagulation with both ASS and clopidogrel
Key inclusion criteria (2 listed)
- Elective vascular surgical patients with long-term medication (at least 5 days) with ASS and clopidogrel
- Age above 18 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of participants with an activated area under the curve in ASPI test
Time frame: 30 minutes
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.
1 secondary outcome
Numbers of participants with an activated area under the curve in TRAP test and ADP test
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
Related trials for Anticoagulation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with an activated area under the curve in ASPI test (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2011.