Heart FailureNCT02448901
Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography
An observational study of Heart Failure, run by LifeBridge Health at 1 site in United States.
Trial summary
The influence of different doses of edoxaban on physical characteristics of the clot and thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood samples collected from patients treated for heart failure (with and without hypercoagulability) and from healthy volunteers (with and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Edoxaban
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers (n=20) Heart Failure Patients (n=20)
Who may be able to join
- Patients with heart failure (class I-IV) are eligible for enrollment:
- Patient must have documented symptomatic chronic HF for at least 3 months prior to screening. Exacerbation of chronic HF is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization HF medications.
- Subject must have a documented LVEF of less than or equal to 40% within 3 months of the study. If more than one LVEF is available, the most recent one should be used, but it must be less than or equal to 40%. The ejection fraction will be determined by one of the following methods: echocardiogram, nuclear multigated acquisition (MUGA) scan, cardiac MRI, cardiac CT scan, or left ventriculography.
- Patient must be receiving appropriate HF treatment at the appropriate dosing per guidelines:
- Diuretic (required for study entry) Renin-angiotensin system (RAS) inhibitors such as an ACE inhibitor, or ARB if intolerant of ACE inhibitor, or vasodilator therapy such as hydralazine or nitrates if intolerant to ACE inhibitor and ARB
- Beta blocker therapy
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- Aldosterone antagonist therapy.
- Patient must have completed all prophylactic anticoagulation (such as enoxaparin, warfarin, heparin, etc) for at least one week before study.
- Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and is willing to participate in the study.
Who cannot join
- For Healthy Subjects:
- subjects currently on antiplatelet therapy or any other agents that are known to influence platelet function and coagulation.
- For Subjects with Heart Failure:
- Hemodynamic instability, active bleeding and bleeding diatheses, oral anticoagulation therapy, leukocyte count < 3,000/mm3, platelet count < 100,000/mm3, aspartate aminotransferase or alanine aminotransferase levels ≥ 3 times upper normal, and creatinine >2mg/dL.
- Patient has a severe concomitant disease such as: Atrial fibrillation (AFib) or another condition that requires chronic anticoagulation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215
Kevin Bliden, MBA, 410-601-4795, kbliden@lifebridgehealth.org
About this study
The influence of different doses of edoxaban on physical characteristics of the clot and thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood samples collected from patients treated for heart failure (with and without hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This in vitro experiment will help us to:
(i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting properties of edoxaban.
Read the detailed description
Experimental protocol
- On the day of experiment blood samples will be collected in 3.2% citrate tubes.
- One citrated blood tube will be centrifuged to collect plasma for biomarker measurements (C-reactive protein (CRP), fibrinogen, von Willebrand factor (vWF), interleukin (IL)-6, p-selectin, plasminogen activator inhibitor (PAI)-1, matrix metalloproteinase (MMP)-9).
- Blood samples will be incubated with different concentrations of edoxaban (no edoxaban, subtherapeutic range - 30 nM, therapeutic range -300 nM, and supratherapeutic range- 900 nM) (3).
- Cora® Hemostasis Analyzer System (Cora®) will be used to assess qualitative and quantitative assessment of the hemostatic properties of a blood sample in the presence or absence of edoxaban. The CORA is an integrated computer module with Ethernet connection capability and provides continuous resonance-frequency viscoelasticity measurements using a disposable four-channel microfluidic cartridge to determine simultaneous maximal platelet-fibrin clot strength, fibrin clot strength, and response to antiplatelet agents or anticoagulants. The cartridge has four channels - citrated Kaolin (CK) channel that measures platelet-fibrin clot strength, anti-Xa channel, DTI channel and FFC channel that measures contribution of functional fibrinogen.
In addition, using the V-curve software, the following parameters of thrombin generation kinetics will be evaluated from the CK channel- R - Period of time of latency from the time that the blood was placed in the TEG® analyzer until the initial fibrin formation. This represents the enzymatic portion of coagulation.
K - K time is a measure of the speed to reach a certain level of clot strength. This represents clot kinetics.
alpha - measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This represents fibrinogen level.
MA - Maximum Amplitude is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa and represents the ultimate strength of the fibrin clot. This represents platelet function/aggregation.
TMRTG - Time to maximum rate of thrombus generation. MRTG - Maximum rate of thrombus generation. TG - Total thrombus generated. TMRL - Time to maximum rate of lysis MRL - Maximum rate of lysis L - Total lysis D - Delta is the difference between R time and the time of initial split point (SP, mins) of the TEG tracing (R - SP), representing the time interval of greatest clot growth secondary to peak thrombin generation.
- Calibrated Automated Thrombogram® (CAT) System: Lag time, peak thrombin production, mean velocity rate index and endogenous thrombin potential (ETP) will be assessed by calibrated automated thrombogram in platelet poor plasma (Thrombinoscope by Stago).
- Conditions
- Heart Failure
- Being tested
- Edoxaban
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called DU-176b, trade names Savaysa, Lixiana
In vitro study. Various concentrations of Edoxoban added to blood sample and tested
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo
- Responsible party
- Principal investigator, Paul A. Gurbel, LifeBridge Health
- Investigators
- paul gurbel, MD, Principal investigator, Sinai Center for Thrombosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448901
- Sponsor's protocol ID
- 2213
- Status last verified
- May 2015
- First submitted
- 23 Apr 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography
- ClinicalTrials.gov ID
- NCT02448901
- Acronym / sponsor ID
- 2213
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- Daiichi Sankyo
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 May 2015 (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.
The influence of different doses of edoxaban on physical characteristics of the clot and thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood samples collected from patients treated for heart failure (with and without hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This in vitro experiment will help us to:
(i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting properties of edoxaban.
Detailed description
Experimental protocol
- On the day of experiment blood samples will be collected in 3.2% citrate tubes.
- One citrated blood tube will be centrifuged to collect plasma for biomarker measurements (C-reactive protein (CRP), fibrinogen, von Willebrand factor (vWF), interleukin (IL)-6, p-selectin, plasminogen activator inhibitor (PAI)-1, matrix metalloproteinase (MMP)-9).
- Blood samples will be incubated with different concentrations of edoxaban (no edoxaban, subtherapeutic range - 30 nM, therapeutic range -300 nM, and supratherapeutic range- 900 nM) (3).
- Cora® Hemostasis Analyzer System (Cora®) will be used to assess qualitative and quantitative assessment of the hemostatic properties of a blood sample in the presence or absence of edoxaban. The CORA is an integrated computer module with Ethernet connection capability and provides continuous resonance-frequency viscoelasticity measurements using a disposable four-channel microfluidic cartridge to determine simultaneous maximal platelet-fibrin clot strength, fibrin clot strength, and response to antiplatelet agents or anticoagulants. The cartridge has four channels - citrated Kaolin (CK) channel that measures platelet-fibrin clot strength, anti-Xa channel, DTI channel and FFC channel that measures contribution of functional fibrinogen.
In addition, using the V-curve software, the following parameters of thrombin generation kinetics will be evaluated from the CK channel- R - Period of time of latency from the time that the blood was placed in the TEG® analyzer until the initial fibrin formation. This represents the enzymatic portion of coagulation.
K - K time is a measure of the speed to reach a certain level of clot strength. This represents clot kinetics.
alpha - measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This represents fibrinogen level.
MA - Maximum Amplitude is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa and represents the ultimate strength of the fibrin clot. This represents platelet function/aggregation.
TMRTG - Time to maximum rate of thrombus generation. MRTG - Maximum rate of thrombus generation. TG - Total thrombus generated. TMRL - Time to maximum rate of lysis MRL - Maximum rate of lysis L - Total lysis D - Delta is the difference between R time and the time of initial split point (SP, mins) of the TEG tracing (R - SP), representing the time interval of greatest clot growth secondary to peak thrombin generation.
- Calibrated Automated Thrombogram® (CAT) System: Lag time, peak thrombin production, mean velocity rate index and endogenous thrombin potential (ETP) will be assessed by calibrated automated thrombogram in platelet poor plasma (Thrombinoscope by Stago).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers (n=20) Heart Failure Patients (n=20)
Key inclusion criteria (9 listed)
- Patient must have documented symptomatic chronic HF for at least 3 months prior to screening. Exacerbation of chronic HF is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization HF medications.
- Subject must have a documented LVEF of less than or equal to 40% within 3 months of the study. If more than one LVEF is available, the most recent one should be used, but it must be less than or equal to 40%. The ejection fraction will be determined by one of the following methods: echocardiogram, nuclear multigated acquisition (MUGA) scan, cardiac MRI, cardiac CT scan, or left ventriculography.
- Patient must be receiving appropriate HF treatment at the appropriate dosing per guidelines:
- Patient must have completed all prophylactic anticoagulation (such as enoxaparin, warfarin, heparin, etc) for at least one week before study.
- Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and is willing to participate in the study.
Key exclusion criteria (5 listed)
- subjects currently on antiplatelet therapy or any other agents that are known to influence platelet function and coagulation.
- Hemodynamic instability, active bleeding and bleeding diatheses, oral anticoagulation therapy, leukocyte count < 3,000/mm3, platelet count < 100,000/mm3, aspartate aminotransferase or alanine aminotransferase levels ≥ 3 times upper normal, and creatinine >2mg/dL.
- Patient has a severe concomitant disease such as: Atrial fibrillation (AFib) or another condition that requires chronic anticoagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: DU-176b, trade names Savaysa, LixianaIn vitro study. Various concentrations of Edoxoban added to blood sample and tested | Drug | – |
Primary outcome
Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
paul gurbel, MD principal investigator
Sinai Center for Thrombosis Research
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 Heart Failure, run by LifeBridge Health at 1 site in United States.
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 9 inclusion and 5 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 20 May 2015. 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 United States. 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?
Contact Kevin P Bliden, BS, MBA (410-601-4795, kbliden@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s) (time frame: 1 year). 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 20 May 2015.