Hemodialysis Access FailurePhase 4NCT04489849
Apixaban for Prevention of Post-angioplasty Thrombosis of Hemodialysis Vascular Access
A Phase 4 study testing Apixaban 2.5 MG in people with Hemodialysis Access Failure, run by National Taiwan University Hospital Hsin-Chu Branch at 2 sites in Taiwan.
Trial summary
Taiwan was among the countries with high prevalence of end stage renal disease (ESRD), and more than 90% of ESRD patients in Taiwan received hemodialysis. Thrombosis are the most common complications of hemodialysis vascular access, with an annual incidence of 30-65% for dialysis grafts. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Apixaban 2.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Mar 2020to 14 Jun 2022
- Phase
- Phase 4
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-99 years old
- End stage renal disease, patients on maintenance hemodialysis for at least one month
- Dialysis vascular access thrombosis, documented by angiograph, and thrombosis was salvaged by endovascular or surgical procedures successfully
Who cannot join
- History of intracranial hemorrhage
- Major bleeding in recent 3 months, which defined as Bleeding Academic Research Consortium (BARC) 2 criteria
- Concomitant use of dual antiplatelet agent (aspirin and clopidogrel)
- Concomitant use of ticagrelor
- Concomitant use of warfarin
- Planned to receive surgery in recent 3 months
Show all 11Show fewer
- Planned to receive coronary stents in recent 3 months
- Hemoglobin < 7.0 g/dL or Platelet count < 80 K/uL
- Moderate or severe liver dysfunction, defined as Child-Pugh score > 6
- Patient received bioprosthetic or mechanical heart valve
- Cannot signed informed consent
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital HsinChu branch
Hsinchu, 300
NienChu Kui, hch01215@hch.gov.tw
- Recruiting
National Taiwan University Hospital,HsinChu branch
Hsinchu, 300
NienChu Kui, hch01215@hch.gov.tw
Tsung-Yu Ko, MD
About this study
Taiwan was among the countries with high prevalence of end stage renal disease (ESRD), and more than 90% of ESRD patients in Taiwan received hemodialysis. Thrombosis are the most common complications of hemodialysis vascular access, with an annual incidence of 30-65% for dialysis grafts. Although endovascular thrombectomy is effective and convenient, the recurrence rate was high, nearly 50% in three months.
The mechanisms of dialysis vascular access thrombosis were multi-factorial, including flow stasis, endothelial injury and hypercoagulability. Our recent study showed that 63% of patients with early thrombosis after angioplasty had at least one thrombophilic factor. Nonetheless, no antithrombotic regimen has been validated to be effective for prevention of thrombosis, either primary or secondary prevention. Novel oral anticoagulants (NOACs) have shown comparable efficacy as VKA with significant decrease in major bleeding. Furthermore, NOACs have the advantage of rapid onset without the need for titration, which should be more effective in the critical period early after thrombectomy. NOAC have almost replaced the role of VKA for the prevention of stroke in patients with atrial fibrillation. They also replaced oral and parenteral anticoagulants in the treatment and prevention of deep vein thrombosis. Among the 4 available NOACs today, only apixaban had received approval by the US Food and Drug Administration (FDA) to be used in patients with ESRD for stroke prevention in atrial fibrillation.
In consideration of the trade-off between thrombotic and bleeding risk, we aimed at secondary prevention for patients with a thrombosis event after a successful thrombectomy procedure. Apixaban would be used because it was approved by FDA for the use of hemodialysis patients, with a risk of major bleeding of 5% for 3 months. Furthermore, considering the ethnic (Asia population) and clinical (ESRD and high bleeding risk) background of our target population, 2.5 mg twice daily dose was chosen in this study to minimize the bleeding risk. This study is a multi-center, prospective, open-labeled, randomized trial with blinded evaluation of all outcomes (PROBE design). We anticipated to enroll 150 patients, with 1:1 randomization to apixaban and control group (no antithrombotic agent). The duration of therapy will be 3 months and the primary outcome is the time to recurrent thrombotic event. Secondary outcomes included frequency of thrombosis, repeat interventions, and bleeding events. We hypothesized that apixaban could prolong the thrombosis-free interval after a successful thrombectomy procedure of hemodialysis vascular access.
- Conditions
- Hemodialysis Access Failure
- Being tested
- Apixaban 2.5 MG, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 MGDrug
apixaban 2.5mg BID for 3 months in experimental group
Active ControlOther
Medication other than anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Apixaban 2.5mg BID Receives: Drug: Apixaban 2.5 MG |
| Control | Active comparator | Other treatment except oral anticoagulant Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis rate
Measured: 3 months
Secondary outcomes (3)
Frequency of thrombosis
Measured: 3 months
Frequency of angioplasty for vascular access
Measured: 3 months
Major bleeding event
Major bleeding according to BARC2 criteria
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start14 Mar 2020
- Primary completion14 Mar 2022 (estimated)
- Study completion14 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Access 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489849
- Sponsor's protocol ID
- 108-029-F
- Status last verified
- Jul 2020
- First submitted
- 25 May 2020
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for Prevention of Post-angioplasty Thrombosis of Hemodialysis Vascular Access
- ClinicalTrials.gov ID
- NCT04489849
- Acronym / sponsor ID
- 108-029-F
- Conditions
- Hemodialysis Access Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 14 Mar 2022 (estimated)
- Study completion
- 14 Jun 2022 (estimated)
- First posted
- 28 Jul 2020 (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.
Taiwan was among the countries with high prevalence of end stage renal disease (ESRD), and more than 90% of ESRD patients in Taiwan received hemodialysis. Thrombosis are the most common complications of hemodialysis vascular access, with an annual incidence of 30-65% for dialysis grafts. Although endovascular thrombectomy is effective and convenient, the recurrence rate was high, nearly 50% in three months.
The mechanisms of dialysis vascular access thrombosis were multi-factorial, including flow stasis, endothelial injury and hypercoagulability. Our recent study showed that 63% of patients with early thrombosis after angioplasty had at least one thrombophilic factor. Nonetheless, no antithrombotic regimen has been validated to be effective for prevention of thrombosis, either primary or secondary prevention. Novel oral anticoagulants (NOACs) have shown comparable efficacy as VKA with significant decrease in major bleeding. Furthermore, NOACs have the advantage of rapid onset without the need for titration, which should be more effective in the critical period early after thrombectomy. NOAC have almost replaced the role of VKA for the prevention of stroke in patients with atrial fibrillation. They also replaced oral and parenteral anticoagulants in the treatment and prevention of deep vein thrombosis. Among the 4 available NOACs today, only apixaban had received approval by the US Food and Drug Administration (FDA) to be used in patients with ESRD for stroke prevention in atrial fibrillation.
In consideration of the trade-off between thrombotic and bleeding risk, we aimed at secondary prevention for patients with a thrombosis event after a successful thrombectomy procedure. Apixaban would be used because it was approved by FDA for the use of hemodialysis patients, with a risk of major bleeding of 5% for 3 months. Furthermore, considering the ethnic (Asia population) and clinical (ESRD and high bleeding risk) background of our target population, 2.5 mg twice daily dose was chosen in this study to minimize the bleeding risk. This study is a multi-center, prospective, open-labeled, randomized trial with blinded evaluation of all outcomes (PROBE design). We anticipated to enroll 150 patients, with 1:1 randomization to apixaban and control group (no antithrombotic agent). The duration of therapy will be 3 months and the primary outcome is the time to recurrent thrombotic event. Secondary outcomes included frequency of thrombosis, repeat interventions, and bleeding events. We hypothesized that apixaban could prolong the thrombosis-free interval after a successful thrombectomy procedure of hemodialysis vascular access.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixaban 2.5 MGApixaban 2.5mg BID |
| Control | Active comparator | Other: Active ControlOther treatment except oral anticoagulant |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-99 years old
- End stage renal disease, patients on maintenance hemodialysis for at least one month
- Dialysis vascular access thrombosis, documented by angiograph, and thrombosis was salvaged by endovascular or surgical procedures successfully
Key exclusion criteria (11 listed)
- History of intracranial hemorrhage
- Major bleeding in recent 3 months, which defined as Bleeding Academic Research Consortium (BARC) 2 criteria
- Concomitant use of dual antiplatelet agent (aspirin and clopidogrel)
- Concomitant use of ticagrelor
- Concomitant use of warfarin
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 2.5 MGapixaban 2.5mg BID for 3 months in experimental group | Drug | Apixaban |
| Active ControlMedication other than anticoagulation | Other | Control |
Primary outcome
Thrombosis rate
Time frame: 3 months
3 secondary outcomes
Frequency of thrombosis
Time frame: 3 months
Frequency of angioplasty for vascular access
Time frame: 3 months
Major bleeding event
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban 2.5 MG in people with Hemodialysis Access Failure, run by National Taiwan University Hospital Hsin-Chu Branch at 2 sites in Taiwan.
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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tsung-Yu Ko, MD (03-5326151, sonicwind1022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis rate (time frame: 3 months). 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 28 Jul 2020.