Liver CirrhosisPhase 2CIRROACNCT05869591
DOAC in Patients with Child a or B Liver Cirrhosis
A Phase 2 study testing Apixaban 5 MG [Eliquis] and Edoxaban 60 MG [Lixiana] in people with Liver Cirrhosis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Apixaban 5 MG [Eliquis] and Edoxaban 60 MG [Lixiana]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jan 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patient with previously diagnosed liver cirrhosis Child A or B
- Written informed consent
Who cannot join
- Pregnancy
- Oesophageal varices with grade superior to 1 or with red signs
- Active ulcer disease of the gastrointestinal tract
- History of haemorrhagic stroke
- Severe uncontrolled hypertension
- Recent brain, spinal or ophthalmic surgery
Show all 11Show fewer
- Kidney function inadequate for DOAC treatment
- Concomitant treatment with anti-platelet drugs
- Concomitant treatment with anticoagulant drugs (VKA, LMWH, DOAC)
- Any contraindications for DOAC administration
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Lorenzo Alberio, Prof. Dr., +41 21 314 01 71, lorenzo.alberio@chuv.ch
About this study
Official title: Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis
The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients.
Participants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days.
The results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC
Read the detailed description
Patients with liver cirrhosis (LC) have a higher risk to develop venous thromboembolism (VTE), in particular portal vein thrombosis (PVT) and the risk is increased with advanced liver disease. Some studies have shown that anticoagulant therapy in patients with LC and PVT could improve their prognosis by reducing liver decompensation, variceal bleeding, encephalopathy, and portal hypertension complications. Direct oral anticoagulant drugs (DOAC) seem to be as effective and safe as traditional anticoagulant drugs [vitamin K antagonists (VKA) and low molecular weight heparins (LMWH)]. Moreover, some studies showed lower bleeding rate and more recanalization of PVT with DOAC than traditional anticoagulant drugs. However, physicians are still reluctant to anticoagulate this population. This is well illustrated by the lower rate of adequate prophylaxis during in-hospital treatment in LC compared to other patients. This is probably due to two reasons. First, the fear of inducing bleeding in patients with increased INR and persistent thrombocytopenia, although it has been shown that the VTE risk is independent of INR and thrombocytopenia. Second, there is still a large knowledge gap on the effects of the various anticoagulant drugs and on the best anticoagulant molecule to employ in this population. Indeed, both VKA and LMWH present several disadvantages in LC patients. VKA are not recommended because of unreliable INR (already increased at baseline) and the risk of pseudo-therapeutic INR values. As for LMWH, a non-negligible increase of bleeding complications has been observed in LC patients. It has been demonstrated that patients with LC exhibit a lower anti-Xa activity when treated with LMWH compared to other patients and that after spiking their plasma with a given amount of LMWH, the measured anti-Xa activity was lower than in plasma from healthy controls. Of note, the anti-Xa activity was corrected after supplementation of antithrombin. In case of anti-Xa monitoring, this could lead to LMWH overdosing. In fact, despite a lower anti-Xa activity, the anticoagulant effect of LMWH seems to be increased in LC patients when assessed by thrombin generation, possibly because of antithrombin-independent antithrombotic actions of LMWH. Therefore, also LMWH are not ideal for LC patients. Nevertheless, both VKA and LMWH are the anticoagulant most frequently administrated to patients with LC, possibly also because of limited data about DOAC. In fact, patients with advanced liver disease or "hepatic coagulopathies" have been excluded from clinical trials investigating DOAC.
DOAC (apixaban, rivaroxaban, edoxaban, and dabigatran) represent an alternative to VKA and LMWH with specific advantages, particularly the oral intake and a direct action on coagulation factors. Different studies showed similar to lower bleeding rates in cirrhotic patients on DOAC compared to cirrhotic patients treated with warfarin or heparins. This suggests that DOAC are possibly a safe and effective alternative to VKA and LMWH. However, before performing large randomised controlled trials, the effect of specific DOAC in LC should be further studied, to select the ideal molecule.
- Conditions
- Liver Cirrhosis
- Being tested
- Apixaban 5 MG [Eliquis], Edoxaban 60 MG [Lixiana]
- Keywords
- Cirrhosis, DOAC, Thrombin generation, Anticoagulation
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 5 MG [Eliquis]Drug
Pharmacokinetics and pharmacodynamics assessment of apixaban in patients with Child A or B liver cirrhosis
Edoxaban 60 MG [Lixiana]Drug
Pharmacokinetics and pharmacodynamics assessment of edoxaban in patients with Child A or B liver cirrhosis
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic patients with Child A or B under apixaban | Experimental | Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of apixaban (Eliquis®) for 7 consecutive days.
Blood samples will be collected just before and after apixban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.
In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough apixaban levels will be measured. Receives: Drug: Apixaban 5 MG [Eliquis] |
| Cirrrhotic patients with Child A or B under edoxaban | Experimental | Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of edoxaban (Lixiana®) for 7 consecutive days.
Blood samples will be collected just before and after edoxaban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.
In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough edoxaban levels will be measured. Receives: Drug: Edoxaban 60 MG [Lixiana] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from thrombin generation parameters before and after apixaban (Eliquis®) intake
Global thrombin generation assay will be performed using ST Genesia (Stago, Asnière-sur-Seine, France) with Drugscreen reagents (high tissue factor concentration) will be used and all thrombin generation parameters will be retrieved.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last pill intake.
Changes from thrombin generation parameters before and after edoxaban (Lixiana®) intake
Global thrombin generation assay will be performed using ST Genesia (Stago, Asnière-sur-Seine, France) with Drugscreen reagents (high tissue factor concentration) will be used and all thrombin generation parameters will be retrieved.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last pill intake.
Changes from peak and trough levels of apixaban (Eliquis ®)
Concentration of DOAC will be assessed with specific anti-Xa assays using Sysmex CS5100 coagulation analyser (Siemens Healthcare, Erlangen, Germany) and reagents: Hyphen Biophen® Heparin (Hyphen BioMed, Neuville-sur-Oise, France).
Measured: At day 1, at peak level (2 hours after intake). At day 3, at steady state (before intake) and at peak level (2 hours after intake). A day 8 at residual concentration (24 hours after last pill intake). At day 9, 48 hours after last intake.
Changes from peak and trough levels of edoxaban (Lixiana ®)
Concentration of DOAC will be assessed with specific anti-Xa assays using Sysmex CS5100 coagulation analyser (Siemens Healthcare, Erlangen, Germany) and reagents: Hyphen Biophen® Heparin (Hyphen BioMed, Neuville-sur-Oise, France).
Measured: At day 1, at peak level (2 hours after intake). At day 3, at steady state (before intake) and at peak level (2 hours after intake). A day 8 at residual concentration (24 hours after last pill intake). At day 9, 48 hours after last intake.
Secondary outcomes (7)
Changes from Thrombin-antithrombin complex (TAT) concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
In vivo markers of coagulation as TAT (in ng/ml) will be measured by a quantitative enzyme immunoassay (ELISA), according to the protocol of the manufactures (Enzygnost® TAT micro Siemens). The absorbance will be measured using a Dynex microplate reader at 450 nm.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from Thrombin-antithrombin complex (TAT) concentration before and after intake of edoxaban (Lixiana ®) for one week in patients with Child A or B liver cirrhosis.
In vivo markers of coagulation as TAT (in ng/ml) will be measured by a quantitative enzyme immunoassay (ELISA), according to the protocol of the manufactures (Enzygnost® TAT micro Siemens). The absorbance will be measured using a Dynex microplate reader at 450 nm.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from prothrombin activation fragments 1+2 (F1+2) concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
In vivo markers of coagulation as F1+2 (in pmol/l) will be measured by a quantitative enzyme immunoassay (ELISA), according to the protocol of the manufactures (Enzygnost® F1+2 micro Siemens). The absorbance will be measured using a Dynex microplate reader at 492 nm.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from prothrombin activation fragments 1+2 (F1+2) concentration before and after intake of edoxaban (Lixiana®) for one week in patients with Child A or B liver cirrhosis.
In vivo markers of coagulation as F1+2 (in pmol/l) will be measured by a quantitative enzyme immunoassay (ELISA), according to the protocol of the manufactures (Enzygnost® F1+2 micro Siemens). The absorbance will be measured using a Dynex microplate reader at 492 nm.
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from D-dimers concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
D-Dimers concentrations (in ng/ml) will be measured by an automated quantitative immunoassay, according to the manufacturer's instructions (INNOVANCE® D-dimer).
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from D-dimers concentration before and after intake of edoxaban (Lixiana®) for one week in patients with Child A or B liver cirrhosis.
D-Dimers concentrations (in ng/ml) will be measured by an automated quantitative immunoassay, according to the manufacturer's instructions (INNOVANCE® D-dimer).
Measured: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Safety analysis with the identification of specific AEs and SAEs
Major and clinically relevant bleeding events will be retrieved.
Measured: From day 1 to day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start18 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo ALBERIO, Centre Hospitalier Universitaire Vaudois
- Investigators
- Lorenzo Alberio, Prof Dr. med, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869591
- Sponsor's protocol ID
- CER-VD 2022-01395
- Acronym
- CIRROAC
- Status last verified
- Feb 2025
- First submitted
- 3 May 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05869591
- Acronym / sponsor ID
- CIRROAC / CER-VD 2022-01395
- Conditions
- Liver Cirrhosis
- Keywords
- Cirrhosis, DOAC, Thrombin generation, Anticoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 May 2023 (actual)
- 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 goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients.
Participants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days.
The results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC
Detailed description
Patients with liver cirrhosis (LC) have a higher risk to develop venous thromboembolism (VTE), in particular portal vein thrombosis (PVT) and the risk is increased with advanced liver disease. Some studies have shown that anticoagulant therapy in patients with LC and PVT could improve their prognosis by reducing liver decompensation, variceal bleeding, encephalopathy, and portal hypertension complications. Direct oral anticoagulant drugs (DOAC) seem to be as effective and safe as traditional anticoagulant drugs [vitamin K antagonists (VKA) and low molecular weight heparins (LMWH)]. Moreover, some studies showed lower bleeding rate and more recanalization of PVT with DOAC than traditional anticoagulant drugs. However, physicians are still reluctant to anticoagulate this population. This is well illustrated by the lower rate of adequate prophylaxis during in-hospital treatment in LC compared to other patients. This is probably due to two reasons. First, the fear of inducing bleeding in patients with increased INR and persistent thrombocytopenia, although it has been shown that the VTE risk is independent of INR and thrombocytopenia. Second, there is still a large knowledge gap on the effects of the various anticoagulant drugs and on the best anticoagulant molecule to employ in this population. Indeed, both VKA and LMWH present several disadvantages in LC patients. VKA are not recommended because of unreliable INR (already increased at baseline) and the risk of pseudo-therapeutic INR values. As for LMWH, a non-negligible increase of bleeding complications has been observed in LC patients. It has been demonstrated that patients with LC exhibit a lower anti-Xa activity when treated with LMWH compared to other patients and that after spiking their plasma with a given amount of LMWH, the measured anti-Xa activity was lower than in plasma from healthy controls. Of note, the anti-Xa activity was corrected after supplementation of antithrombin. In case of anti-Xa monitoring, this could lead to LMWH overdosing. In fact, despite a lower anti-Xa activity, the anticoagulant effect of LMWH seems to be increased in LC patients when assessed by thrombin generation, possibly because of antithrombin-independent antithrombotic actions of LMWH. Therefore, also LMWH are not ideal for LC patients. Nevertheless, both VKA and LMWH are the anticoagulant most frequently administrated to patients with LC, possibly also because of limited data about DOAC. In fact, patients with advanced liver disease or "hepatic coagulopathies" have been excluded from clinical trials investigating DOAC.
DOAC (apixaban, rivaroxaban, edoxaban, and dabigatran) represent an alternative to VKA and LMWH with specific advantages, particularly the oral intake and a direct action on coagulation factors. Different studies showed similar to lower bleeding rates in cirrhotic patients on DOAC compared to cirrhotic patients treated with warfarin or heparins. This suggests that DOAC are possibly a safe and effective alternative to VKA and LMWH. However, before performing large randomised controlled trials, the effect of specific DOAC in LC should be further studied, to select the ideal molecule.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic patients with Child A or B under apixaban | Experimental | Drug: Apixaban 5 MG [Eliquis]Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of apixaban (Eliquis®) for 7 consecutive days. Blood samples will be collected just before and after apixban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9. In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough apixaban levels will be measured. |
| Cirrrhotic patients with Child A or B under edoxaban | Experimental | Drug: Edoxaban 60 MG [Lixiana]Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of edoxaban (Lixiana®) for 7 consecutive days. Blood samples will be collected just before and after edoxaban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9. In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters [ST Genesia (Drugscreen)], as well as peak and trough edoxaban levels will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patient with previously diagnosed liver cirrhosis Child A or B
- Written informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Oesophageal varices with grade superior to 1 or with red signs
- Active ulcer disease of the gastrointestinal tract
- History of haemorrhagic stroke
- Severe uncontrolled hypertension
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 |
|---|---|---|
| Apixaban 5 MG [Eliquis]Pharmacokinetics and pharmacodynamics assessment of apixaban in patients with Child A or B liver cirrhosis | Drug | Cirrhotic patients with Child A or B under apixaban |
| Edoxaban 60 MG [Lixiana]Pharmacokinetics and pharmacodynamics assessment of edoxaban in patients with Child A or B liver cirrhosis | Drug | Cirrrhotic patients with Child A or B under edoxaban |
Primary outcome
Changes from thrombin generation parameters before and after apixaban (Eliquis®) intake
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last pill intake.
Global thrombin generation assay will be performed using ST Genesia (Stago, Asnière-sur-Seine, France) with Drugscreen reagents (high tissue factor concentration) will be used and all thrombin generation parameters will be retrieved.
Changes from thrombin generation parameters before and after edoxaban (Lixiana®) intake
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last pill intake.
Global thrombin generation assay will be performed using ST Genesia (Stago, Asnière-sur-Seine, France) with Drugscreen reagents (high tissue factor concentration) will be used and all thrombin generation parameters will be retrieved.
Changes from peak and trough levels of apixaban (Eliquis ®)
Time frame: At day 1, at peak level (2 hours after intake). At day 3, at steady state (before intake) and at peak level (2 hours after intake). A day 8 at residual concentration (24 hours after last pill intake). At day 9, 48 hours after last intake.
Concentration of DOAC will be assessed with specific anti-Xa assays using Sysmex CS5100 coagulation analyser (Siemens Healthcare, Erlangen, Germany) and reagents: Hyphen Biophen® Heparin (Hyphen BioMed, Neuville-sur-Oise, France).
Changes from peak and trough levels of edoxaban (Lixiana ®)
Time frame: At day 1, at peak level (2 hours after intake). At day 3, at steady state (before intake) and at peak level (2 hours after intake). A day 8 at residual concentration (24 hours after last pill intake). At day 9, 48 hours after last intake.
Concentration of DOAC will be assessed with specific anti-Xa assays using Sysmex CS5100 coagulation analyser (Siemens Healthcare, Erlangen, Germany) and reagents: Hyphen Biophen® Heparin (Hyphen BioMed, Neuville-sur-Oise, France).
7 secondary outcomes
Changes from Thrombin-antithrombin complex (TAT) concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from Thrombin-antithrombin complex (TAT) concentration before and after intake of edoxaban (Lixiana ®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from prothrombin activation fragments 1+2 (F1+2) concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from prothrombin activation fragments 1+2 (F1+2) concentration before and after intake of edoxaban (Lixiana®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from D-dimers concentration before and after intake of apixaban (Eliquis®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Changes from D-dimers concentration before and after intake of edoxaban (Lixiana®) for one week in patients with Child A or B liver cirrhosis.
Time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last DOAC pill intake.
Safety analysis with the identification of specific AEs and SAEs
Time frame: From day 1 to day 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Lorenzo Alberio, Prof Dr. med principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban 5 MG [Eliquis] and Edoxaban 60 MG [Lixiana] in people with Liver Cirrhosis, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 Switzerland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Alberio, Prof Dr. med (0041213140171, lorenzo.alberio@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from thrombin generation parameters before and after apixaban (Eliquis®) intake (time frame: At day 1 and day 3 before DOAC intake and 2 hours after intake. At day 8, 24 hours after last pill intake.). The study lists 4 primary outcomes in all. 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 13 Feb 2025.