Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation
NCT ID: NCT05679024
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1400 participants
INTERVENTIONAL
2023-02-17
2028-12-31
Brief Summary
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The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.
Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.
Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\* \<20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is \<15 ml/min/1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.
The exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.
Interventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.
Outcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)
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Detailed Description
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Rationale to study design: There are no previous randomized controlled clinical trials in this study population. The SACK study is conducted in approximately 50 sites in Sweden, Finland, Norway, Iceland and Poland, and additional European countries, if necessary. In Sweden, the study will be register-randomized (via the national Swedish Renal Register \[SNR\]) whereas the other countries in the study will include patients in a traditional way for clinical trials.
The study design will be an individually randomized two-armed parallel-group design. Apixaban will be prescribed and renewed by the local investigator via regular prescription or distributed by the investigating site at regular intervals in all participating countries. Due to open-label prescription and safety reasons, the study will be conducted as an open-label trial with end-point evaluation. Patients who are randomized to apixaban and those who are randomized to standard of care with no anti-coagulation will receive all other guideline-recommended standard of care treatments. Patients already on prior warfarin or apixaban therapy, or on regular low molecular weight heparin (LMWH) can also be randomized to either treatment arm (their current anticoagulation is discontinued at the inclusion visit) after an individualized risk assessment. At inclusion, patients will provide routine blood samples including hemoglobin, eGFR, and coagulation parameters.
The end of the clinical study for each individual patient is defined as the End of Study (EoS) visit. The EoS for a patient is after 72 months or when 247 primary events have been reached, whichever comes first. An interim analysis will take place after 1000 patient-years with the purpose to evaluate event rate and to be able to closer determine the exact number of patients and duration of the trial. The end of the clinical trial is defined as the last visit of the last subject in the study (LVLS).
A Data and Safety Monitoring Board (DSMB) will supervise this study, and primary safety and efficacy endpoints and major bleedings will additionally be evaluated by independent external reviewers according to a predefined Central Event Adjudication charter.
Exploratory outcomes: Time to first thromboembolic event defined as a composite of deep vein thrombosis, pulmonary embolism, transient ischemic attack Time to dialysis access thrombosis Time to kidney replacement therapy Delayed graft function in patients undergoing kidney transplantation Thrombosis of renal artery or vein in patients undergoing kidney transplantation
Among the secondary safety outcomes are time to major bleeding according to ISTH criteria. We are especially interested in the safety outcomes of the subgroup undergoing a kidney transplantation from the waiting list and therefore we have an extended protocol for those participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apixaban 2.5 mg twice daily and standard of care
Apixaban 2.5 mg twice daily (low dose) and all other standard of care
Apixaban 2.5 milligram Oral Tablet
Oral Tablet
Standard of care and no anticoagulation
All other Standard of care and no anticoagulation
No interventions assigned to this group
Interventions
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Apixaban 2.5 milligram Oral Tablet
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older
3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\* \<20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is \<15 ml/min/1.73 m2 due to CKD during the last year (12 months).
4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)
5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation
6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment
Exclusion Criteria
1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study
3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).
4. Any contraindication for anticoagulation including
1. endocarditis
2. documented intolerance for apixaban
3. liver disease with documented coagulation disorder
4. pregnancy or breast feeding
5. Active bleeding or serious bleeding within 3 months, or
1. documented hemorrhagic blood dyscrasia
2. patients currently receiving dual antiplatelet therapy
6. Planned for surgery
1. kidney transplantation with a living donor within 3 months
2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited
3. valvular heart disease surgery
7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors
8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol)
Being active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.
18 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Responsible Party
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Principal Investigators
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Marie Evans, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Maria Svensson, Prof
Role: STUDY_CHAIR
Uppsala University
Locations
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Helsingfors University hospital
Helsinki, , Finland
Tampere hospital
Tampere, , Finland
Turku hospital
Turku, , Finland
Landspitali, the National University hospital of Iceland
Reykjavik, , Iceland
Oslo Akershus
Oslo, , Norway
Oslo Universitetssjukhus Ullevål
Oslo, , Norway
Stavanger hospital
Stavanger, , Norway
Tromsö hospital
Tromsø, , Norway
Vestfold hospital
Tønsberg, , Norway
Falun hospital
Falun, Dalarna County, Sweden
Östersund hospital
Östersund, Jämtland County, Sweden
Lasarettet i Falun
Falun, Region Dalarna, Sweden
Mora sjukhus
Mora, Region Dalarna, Sweden
Länssjukhuset Kalmar
Kalmar, Region Kalmar Län, Sweden
Kalix hospital
Kalix, Region Norrbotten, Sweden
Skånes University hospital Lund
Lund, Region Skåne, Sweden
Skånes University hospital Malmö
Malmo, Region Skåne, Sweden
Norrland University hospital Umeå
Umeå, Region Västerbotten, Sweden
Sundsvall
Sundsvall, Region Västernorrland, Sweden
Västmanlands sjukhus Västerås
Västerås, Region Västmanland, Sweden
Borås sjukhus
Borås, Region Västra Götaland, Sweden
Sahlgrenska University hospital
Gothenburg, Region Västra Götaland, Sweden
Skaraborg hospital Skövde
Skövde, Region Västra Götaland, Sweden
University hospital Örebro
Örebro, Region Örebro Län, Sweden
Linköping University hospital
Linköping, Region Östergötland, Sweden
Länssjukhuset Ryhov
Jönköping, , Sweden
Karlshamns sjukhus
Karlshamn, , Sweden
Karlstad Central hospital
Karlstad, , Sweden
Norrköpings sjukhus
Norrköping, , Sweden
Skellefteå hospital
Skellefteå, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
Danderyd sjukhus AB
Stockholm, , Sweden
Akdemiska sjukhuset Uppsala
Uppsala, , Sweden
Varberg hospital
Varberg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Helsingfors U hospital, MD
Role: primary
Satu Mäkelä, MD
Role: primary
Tapio Hellman, MD
Role: primary
Sunna Snaedal, MD, PhD
Role: primary
Asta Jonasdottir, MD, PhD
Role: backup
Kristyna Parker, MD
Role: primary
Eva Staal
Role: primary
Anna Sahlander, MD
Role: primary
Jan Flesche, MD
Role: primary
Anna Sahlander, MD
Role: primary
Hans Furuland, MD
Role: primary
Nikolaos Rigas, MD
Role: primary
Nils Sundberg, MD
Role: primary
Mårten Segelmark, Prof
Role: primary
Anders Christenssen, Prof
Role: primary
Andreas Jonsson, MD
Role: primary
Frida Welander, MD
Role: primary
Josefin Mörtberg, MD
Role: primary
Achim Barth, MD
Role: primary
Gregor Guron, Prof
Role: primary
Anna Wärme, MD
Role: primary
Piotr Jacuszewski, MD
Role: primary
Fredrik Uhlin, RN
Role: primary
Maria Stendahl, PhD
Role: primary
Johan Isaksson, MD
Role: primary
Fredrik Sundelin, MD
Role: primary
Cecilia Johansson, MD, PhD
Role: primary
Karin Bergen, MD
Role: primary
Kerstin Martala, RN
Role: primary
Oscar Bratt, MD
Role: primary
References
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Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
Other Identifiers
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EU CT 2022-501600-10-00
Identifier Type: -
Identifier Source: org_study_id
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