Atrial FibrillationPhase 3APIDP2NCT06045858
Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)
A Phase 3 study testing Anticoagulation Agents in people with Atrial Fibrillation and Peritoneal Dialysis Complication, run by University Hospital, Caen.
Trial summary
Introduction: Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Peritoneal Dialysis Complication
- What is being tested?
- Anticoagulation Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Oct 2027
- Phase
- Phase 3
- 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
- Males and females, age at least 18 years, in ESRD treated with peritoneal dialysis for ≥ 3 months
- Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF
- CHA2DS2-VASc score of ≥ 2.
- For women of childbearing age who are sexually active, use of an effective method of contraception for up to 10 days after the end of treatment and a negative blood pregnancy test at enrollment.
- Signature of informed consent
Who cannot join
- Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin <8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
- Moderate or severe mitral stenosis
- Patients with a history of transient ischemic attack or stroke in the 3 months prior to inclusion
- Patient treated with haemodyalisis
- Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
- Life expectancy < 3 months
Show all 12Show fewer
- Anticipated kidney transplant within the next 3 months
- Individuals covered by Articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, postpartum women, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, minors, individuals under legal protection such as guardianship or trusteeship).
- Women of childbearing age not using a highly effective contraceptive method during the study and up to 10 days after the end of treatment.
- Use of potent inducers of CYP3A4 (particularly rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort (Hypericum perforatum)).
- Use of CYP3A4 and P-gp inhibitors, particularly azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole), HIV protease inhibitors, clarithromycin, and erythromycin.
- Contraindication to anticoagulant treatment, such as antiphospholipid syndrome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Introduction:
Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population.
Read more
Design: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial.
Participants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF.
Setting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers.
Intervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target [2-3] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year.
The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of [2-3] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm.
Primary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl [25-30]ml/min), i.e. 89 patients per group.
Read the detailed description
The prevalence of AF in the general population is estimated to range around 1% depending on age, reaching 8% in patients over 80 years old. This prevalence is of 20% and 14% in patients on hemodialysis and peritoneal dialysis.
In addition, AF is associated with higher morbidity and mortality rates in patients with advanced chronic kidney disease, in contrast with patients with preserved kidney function, with a higher risk of both bleeding and clotting.
In the general population, the novel oral anticoagulants (NOACs) demonstrated a greater safety over warfarin and among 269 patients with CrCl (Creatinine Clearance) 25 to 30 mL/min included in ARISTOTLE trial: apixaban caused less bleeding than warfarin.
Furthermore, warfarin has been recognized as a risk factor for calcific uremic arteriolopathy (calciphylaxis), a rare yet serious complication. Additionally, patients in ESRD appear to have low adherence to warfarin therapy, with time of INR in target range of only 44 to 51% in three randomised controlled trials.
Considering the complex pathophysiology underlying the excess risk of stroke in patients with advanced CKD and the known complications of warfarin therapy, the use of NOACs in these populations may present an appealing alternative.
Four significant reviews conducted in 2022 and 2023, based on randomised controlled trials and cohort studies, assessed both thrombotic and bleeding outcomes associated with anticoagulant use in advanced chronic kidney disease. These reviews highlights the necessity for more randomised controlled trials (RCTs).
The two most significant cohorts to date that compared warfarin versus NOACs yielded important findings are:
- Siontis et al.: they conducted a study involving a larger cohort (2,351 versus 7,053) and found a reduction in major bleeding events with apixaban compared to warfarin, with similar efficacy in dialysis patients.
- Wetmore et al.: they included 3,130 patients versus 9,086, and also found a reduction in major bleeding events with apixaban compared to warfarin in dialysis patients, while maintaining similar efficacy.
In 2023, a thirth cohort study was published, involving 4,313 apixaban users with stage 4 and 5 kidney disease. This study found that the use of 5mg apixaban was associated with a higher risk of bleeding, with no difference in efficacy. These findings supported European dosing recommendations of 2.5mg twice daily, which differ from the U.S. recommendation of 5mg twice daily in patients with atrial fibrillation and severe chronic kidney disease.
Additionally, two recent meta-analyses included the three randomised controlled trials comparing the safety of NOACs versus warfarin. These analyses encompassed a total of 341 patients with atrial fibrillation and end-stage renal disease, with 176 in the NOAC group and 165 in the warfarin group. The results indicated that safety and efficacy outcomes were comparable, with no significant differences in stroke, mortality, or bleeding incidences.
In terms of cardiology recommendations, two meta-analyses involving a total of 10,445 patients with end-stage renal disease (ESRD) and 24,335 patients on dialysis, comparing those who received VKA with those who received no anticoagulation, revealed no significant benefit in preventing ischemic stroke but did indicate an increased risk of bleeding. Consequently, the ESC guidelines do not provide any recommendations regarding the use of NOACs in patients with atrial fibrillation (AF) who also have ESRD or are undergoing dialysis.
The results obtained from randomised controlled trials (RCTs) conducted on hemodialysis patients cannot be extrapolated to peritoneal dialysis patients. The two patient populations are distinct, as peritoneal dialysis patients do not receive heparin-based anticoagulation, which may increase the risk of bleeding events. Additionally, peritoneal dialysis patients do not have arteriovenous fistulas that could potentially lead to bleeding.
Regarding apixaban pharmacokinetics, a preliminary PK study in 2016 by Wang suggested that hemodialysis has a moderate impact on apixaban's plasma concentration. Subsequently, Mavrakanas conducted another PK study, revealing that hemodialysis was linked to supratherapeutic levels of apixaban and recommended a dose reduction.
However, as there was a lack of data on the pharmacokinetics of apixaban in end-stage renal disease (ESRD) patients undergoing peritoneal dialysis, researchers initiated the APIDP1 study with 12 peritoneal dialysis patients. The results showed a very low peritoneal dialysis apixaban clearance, resulting in significantly higher mean AUC in patients treated with PD, 73% higher (p=0.01) than the mean AUC of healthy controls matched by age, weight, and sex. Fung et al. subsequently reported similar pharmacokinetic findings : a proportion of PD patients had supratherapeutics levels even when the reduced dosage 2.5mg twice a day was use. Then Lidgard and Shen, in a 2023 editorial, emphasized the importance of reducing the apixaban dosage for stroke prevention in atrial fibrillation patients undergoing PD treatment, regardless of their age or weight.
Then, APIDP group aimed to conduct a phase III study to compare the safety of apixaban at the reduced dose to adjusted-warfarin in ESRD patients treated with chronic peritoneal dialysis. The study name is APIDP2, the protocol was prepared in accordance to Recommendations for Interventional Trials (SPIRIT) guidelines. The complete study protocol and the SPIRIT checklist are attached as supplement. The flow diagram of the study is illustrated in figure 1.
Objectives To determine in ESRD patients treated with chronic peritoneal dialysis whether apixaban 2.5mg twice daily or dose-adjusted to INR target [2-3] warfarin is safer at one year.
Methods
Trial design APIDP2 is a phase III study with a parallel enrolment, PROBE (prospective randomised open blinded-endpoint) design, one year of follow-up. Open-label administration of anticoagulation was choice because the need to adjust warfarin to targeted international normalized ratio (INR).
Setting Recruitment is scheduled to commence in June 2024 with a total of 178 randomised patients to be included. Considering the suitability of the 20 centers, it is anticipated that data collection will be completed around June 2027.
- Being tested
- Anticoagulation Agents
- Keywords
- peritoneal dialysis, atrial fibrillation, anticoagulation, randomized controlled trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation AgentsDrug
anticoagulation in peritoneal dialysis patients with non valvular atrial fibrillation during one year
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Active comparator | Warfarin (Coumadine): INR target [2.0-3.0] Receives: Drug: Anticoagulation Agents |
| Apixaban | Experimental | Apixaban (Eliquis) at 2.5mg, per os, twice a day Receives: Drug: Anticoagulation Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety primary criterion
at least one event for each participant ISTH major or clinically relevant non-major bleeding cumulated at 12 months
Measured: 0-12 months
Secondary outcomes (1)
Composite efficacy criterion
Composite criterion with at least one event :stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a Haybittle sequential plan (PROC SEQDESIGN, SAS 9.4) with decision rule for better safety (larger than expected effect)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045858
- Sponsor's protocol ID
- 23-164
- Other IDs
- 2023-507544-37-00, 2023
- Acronym
- APIDP2
- Status last verified
- May 2024
- First submitted
- 4 Sep 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the trial has finished and the main trial paper has been published, a fully anonymised trial data set will be available on reasonable request from Clinical Research Unit of University Hospital of Caen, Normandy, France (email: apidp2@chu-caen.fr).
Publications
Ficheux M, Peyro-Saint-Paul L, Balayn D, Lecrux B, Brossier M, Morin A, Lanot A, Peron C, Boulanger M, Brionne M, Beygui F, Parienti JJ, Lobbedez T, Bechade C. Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2). BMJ Open. 2024 Sep 20;14(9):e089353. doi: 10.1136/bmjopen-2024-089353.
PubMed 39306346
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular Atrial Fibrillation: a Prospective, Randomised, Open-label, Blinded End-point Trial (APIDP2)
- ClinicalTrials.gov ID
- NCT06045858
- Acronym / sponsor ID
- APIDP2 / 23-164
- Keywords
- peritoneal dialysis, atrial fibrillation, anticoagulation, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 21 Sep 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.
Introduction:
Several randomised controlled trials have demonstrated that novel oral anticoagulants (NOACs) are safer compared to vitamin K antagonists for the management of non valvular atrial fibrillation (NVAF) to prevent thromboembolic events, in the general population. There is a growing interest in the use of apixaban in patients with End-Stage Renal-Disease (ESRD) undergoing peritoneal dialysis but there is a lack of randomised data in this population.
Design: APIDP2 is a prospective parallel randomised, open-label, blinded endpoint trial.
Participants: Patients with ESRD undergoing chronic Peritoneal Dialysis who have NVAF.
Setting: A total of 178 participants will be recruited from 20 French peritoneal dialysis centers.
Intervention: Eligible patients will be randomly assigned to receive either apixaban at a reduced dose 2.5mg twice daily (dose determined with the previous pharmacokinetic study APIDP1 of apixaban in PD patients) or dose-adjusted to INR target [2-3] coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of one year.
The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to Month 12, assessed according to ISTH score. Secondary outcomes encompass an efficacy composite criterion combining stroke or TIA, cardiovascular death, and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to GUSTO and TIMI criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of [2-3] in the warfarin arm over one year, and AntiXa apixaban activity in case of bleeding events and at 1, 6, and 12 months of follow-up in the apixaban arm.
Primary outcome analysis: To demonstrate that apixaban is safer than warfarin at one year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found in the ARISTOTLE study among patients with CrCl [25-30]ml/min), i.e. 89 patients per group.
Detailed description
The prevalence of AF in the general population is estimated to range around 1% depending on age, reaching 8% in patients over 80 years old. This prevalence is of 20% and 14% in patients on hemodialysis and peritoneal dialysis.
In addition, AF is associated with higher morbidity and mortality rates in patients with advanced chronic kidney disease, in contrast with patients with preserved kidney function, with a higher risk of both bleeding and clotting.
In the general population, the novel oral anticoagulants (NOACs) demonstrated a greater safety over warfarin and among 269 patients with CrCl (Creatinine Clearance) 25 to 30 mL/min included in ARISTOTLE trial: apixaban caused less bleeding than warfarin.
Furthermore, warfarin has been recognized as a risk factor for calcific uremic arteriolopathy (calciphylaxis), a rare yet serious complication. Additionally, patients in ESRD appear to have low adherence to warfarin therapy, with time of INR in target range of only 44 to 51% in three randomised controlled trials.
Considering the complex pathophysiology underlying the excess risk of stroke in patients with advanced CKD and the known complications of warfarin therapy, the use of NOACs in these populations may present an appealing alternative.
Four significant reviews conducted in 2022 and 2023, based on randomised controlled trials and cohort studies, assessed both thrombotic and bleeding outcomes associated with anticoagulant use in advanced chronic kidney disease. These reviews highlights the necessity for more randomised controlled trials (RCTs).
The two most significant cohorts to date that compared warfarin versus NOACs yielded important findings are:
- Siontis et al.: they conducted a study involving a larger cohort (2,351 versus 7,053) and found a reduction in major bleeding events with apixaban compared to warfarin, with similar efficacy in dialysis patients.
- Wetmore et al.: they included 3,130 patients versus 9,086, and also found a reduction in major bleeding events with apixaban compared to warfarin in dialysis patients, while maintaining similar efficacy.
In 2023, a thirth cohort study was published, involving 4,313 apixaban users with stage 4 and 5 kidney disease. This study found that the use of 5mg apixaban was associated with a higher risk of bleeding, with no difference in efficacy. These findings supported European dosing recommendations of 2.5mg twice daily, which differ from the U.S. recommendation of 5mg twice daily in patients with atrial fibrillation and severe chronic kidney disease.
Additionally, two recent meta-analyses included the three randomised controlled trials comparing the safety of NOACs versus warfarin. These analyses encompassed a total of 341 patients with atrial fibrillation and end-stage renal disease, with 176 in the NOAC group and 165 in the warfarin group. The results indicated that safety and efficacy outcomes were comparable, with no significant differences in stroke, mortality, or bleeding incidences.
In terms of cardiology recommendations, two meta-analyses involving a total of 10,445 patients with end-stage renal disease (ESRD) and 24,335 patients on dialysis, comparing those who received VKA with those who received no anticoagulation, revealed no significant benefit in preventing ischemic stroke but did indicate an increased risk of bleeding. Consequently, the ESC guidelines do not provide any recommendations regarding the use of NOACs in patients with atrial fibrillation (AF) who also have ESRD or are undergoing dialysis.
The results obtained from randomised controlled trials (RCTs) conducted on hemodialysis patients cannot be extrapolated to peritoneal dialysis patients. The two patient populations are distinct, as peritoneal dialysis patients do not receive heparin-based anticoagulation, which may increase the risk of bleeding events. Additionally, peritoneal dialysis patients do not have arteriovenous fistulas that could potentially lead to bleeding.
Regarding apixaban pharmacokinetics, a preliminary PK study in 2016 by Wang suggested that hemodialysis has a moderate impact on apixaban's plasma concentration. Subsequently, Mavrakanas conducted another PK study, revealing that hemodialysis was linked to supratherapeutic levels of apixaban and recommended a dose reduction.
However, as there was a lack of data on the pharmacokinetics of apixaban in end-stage renal disease (ESRD) patients undergoing peritoneal dialysis, researchers initiated the APIDP1 study with 12 peritoneal dialysis patients. The results showed a very low peritoneal dialysis apixaban clearance, resulting in significantly higher mean AUC in patients treated with PD, 73% higher (p=0.01) than the mean AUC of healthy controls matched by age, weight, and sex. Fung et al. subsequently reported similar pharmacokinetic findings : a proportion of PD patients had supratherapeutics levels even when the reduced dosage 2.5mg twice a day was use. Then Lidgard and Shen, in a 2023 editorial, emphasized the importance of reducing the apixaban dosage for stroke prevention in atrial fibrillation patients undergoing PD treatment, regardless of their age or weight.
Then, APIDP group aimed to conduct a phase III study to compare the safety of apixaban at the reduced dose to adjusted-warfarin in ESRD patients treated with chronic peritoneal dialysis. The study name is APIDP2, the protocol was prepared in accordance to Recommendations for Interventional Trials (SPIRIT) guidelines. The complete study protocol and the SPIRIT checklist are attached as supplement. The flow diagram of the study is illustrated in figure 1.
Objectives To determine in ESRD patients treated with chronic peritoneal dialysis whether apixaban 2.5mg twice daily or dose-adjusted to INR target [2-3] warfarin is safer at one year.
Methods
Trial design APIDP2 is a phase III study with a parallel enrolment, PROBE (prospective randomised open blinded-endpoint) design, one year of follow-up. Open-label administration of anticoagulation was choice because the need to adjust warfarin to targeted international normalized ratio (INR).
Setting Recruitment is scheduled to commence in June 2024 with a total of 178 randomised patients to be included. Considering the suitability of the 20 centers, it is anticipated that data collection will be completed around June 2027.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a Haybittle sequential plan (PROC SEQDESIGN, SAS 9.4) with decision rule for better safety (larger than expected effect)
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Active comparator | Drug: Anticoagulation AgentsWarfarin (Coumadine): INR target [2.0-3.0] |
| Apixaban | Experimental | Drug: Anticoagulation AgentsApixaban (Eliquis) at 2.5mg, per os, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, age at least 18 years, in ESRD treated with peritoneal dialysis for ≥ 3 months
- Patients with a history of non valvular AF treated by oral anticoagulation or patients initiating oral anticoagulation for a diagnosis of non valvular AF
- CHA2DS2-VASc score of ≥ 2.
- For women of childbearing age who are sexually active, use of an effective method of contraception for up to 10 days after the end of treatment and a negative blood pregnancy test at enrollment.
- Signature of informed consent
Key exclusion criteria (12 listed)
- Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin <8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
- Moderate or severe mitral stenosis
- Patients with a history of transient ischemic attack or stroke in the 3 months prior to inclusion
- Patient treated with haemodyalisis
- Conditions other than non valvular AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
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 |
|---|---|---|
| Anticoagulation Agentsanticoagulation in peritoneal dialysis patients with non valvular atrial fibrillation during one year | Drug | Apixaban, Warfarin |
Primary outcome
Safety primary criterion
Time frame: 0-12 months
at least one event for each participant ISTH major or clinically relevant non-major bleeding cumulated at 12 months
1 secondary outcome
Composite efficacy criterion
Time frame: 0-12 months
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 9 Aug 2024.
- Derived from this study: PubMed 39306346Ficheux M, Peyro-Saint-Paul L, Balayn D, Lecrux B, Brossier M, Morin A, Lanot A, Peron C, Boulanger M, Brionne M, Beygui F, Parienti JJ, Lobbedez T, Bechade C. Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non-valvular atrial fibrillation: protocol for a prospective, randomised, open-label, blinded endpoint trial (APIDP2). BMJ Open. 2024 Sep 20;14(9):e089353. doi: 10.1136/bmjopen-2024-089353.
- Individual participant dataSharing planned: Yes. Once the trial has finished and the main trial paper has been published, a fully anonymised trial data set will be available on reasonable request from Clinical Research Unit of University Hospital of Caen, Normandy, France (email: apidp2@chu-caen.fr).
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anticoagulation Agents in people with Atrial Fibrillation and Peritoneal Dialysis Complication, run by University Hospital, Caen.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Laure Peyro-saint-paul (233 31065342, peyrosaintpaul-l@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety primary criterion (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045858, which also lists 1 linked publication.
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 9 Aug 2024.