Atrial Fibrillation New OnsetPhase 4TASK-POAFNCT05300555
Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery
A Phase 4 study testing Rivaroxaban 20 MG Oral Tablet and Warfarin in people with Atrial Fibrillation New Onset, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Coronary artery bypass graft (CABG) surgery is a common intervention in patients with coronary artery disease (CAD). The presence of new postoperative atrial fibrillation / atrial flutter (POAF) occurs in 15-40% of patients undergoing this procedure, with a high rate of complications, including increased hospital… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- Rivaroxaban 20 MG Oral Tablet and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2021to 1 Nov 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New atrial/flutter fibrillation / flutter lasting more than 12 hours in the postoperative period of CABG
- Individuals in both sex over the age of 18 years
Who cannot join
- Inability to sign the free and informed consent form
- Contraindication to anticoagulant therapy
- Renal dysfunction with eGFR less than 30ml / min / 1.73m² or dialysis therapy
- Patients with previous AF
- Pregnancy
- Concomitant valve surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - University of São Paulo
São Paulo, São Paulo, 05403000
Eduardo Lima, Doctor, +55 11 2661 5352, eduglima@yahoo.com.br
About this study
Coronary artery bypass graft (CABG) surgery is a common intervention in patients with coronary artery disease (CAD). The presence of new postoperative atrial fibrillation / atrial flutter (POAF) occurs in 15-40% of patients undergoing this procedure, with a high rate of complications, including increased hospital length of stay, with a consequent increase in the costs. In addition, the presence of POAF increases the rate of thromboembolic events such as stroke and mortality in the short and long term.
Anticoagulant treatment in patients with atrial fibrillation and atrial flutter (AF) lato sensu is already a well-established therapy in patients at high risk, defined by CHADS-VASC greater than or equal to 2. The use of direct-acting anticoagulants (DOACS) is standard therapy for those patients. In the POAF scenario, there is a recommendation for anticoagulation in high-risk patients for at least 30 days, however, despite being an entity with a poor prognosis in the short and long term, it is an undertreated entity. At present, there is no evidence of anticoagulant treatment of POAF with DOACS, and warfarin is the standard therapy. Warfarin is a drug that needs laboratory control of prothrombin time (PT) and anticoagulation bridge with other anticoagulants, usually using heparin and enoxaparin. We believe that because warfarin is the standard drug in this scenario, it is not prescribed on a regular basis, since it increases costs, length of hospital stay and is less effective than DOACS in AF lato sensu.
Read more
Thus, the research project intends to compare the cost-effectiveness, assessed by QALY, related to the warfarin prescription strategy associated with bridge anticoagulation versus the rivaroxaban prescription in patients who presented POAF with a minimum duration of 12 hours or AF that requires intervention. Medications will be started during hospitalization. After randomization, anticoagulant medication will be started within 24 hours. The patient will be reassessed in 30 days and if there is no evidence of maintenance of AF, the anticoagulant medication will be discontinued and the standard treatment for CAD will be maintained. Secondary outcomes will be: clinical outcomes, such as: (1) Death; (2) stroke; (3) myocardial infarction (MI); (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection. The safety outcome will be the bleeding assessment according to the bleeding score of the ISTH (International Society on Thrombosis and Haemostasis).
Considering that POAF is a prevalent entity and associated with a worse prognosis in the short and long term, as well as despite recommendations for guidelines to keep these patients anticoagulated, it is noted that the prescription of anticoagulation at hospital discharge is low. Considering that there is no clear evidence in studies on the use of DOAC in this population, we understand that the search for medications that lead to better cost-benefit, as well as better dosage and bleeding rates not lower than the use of warfarin, could lead to a higher rate prescribing anticoagulants for these patients, reducing costs, clinical and mortality outcomes.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- Rivaroxaban 20 MG Oral Tablet, Warfarin
- Keywords
- ANTICOAGULANTS, CORONARY ARTERY BYPASS GRAFT, ATRIAL FIBRILLATION, POST OPERATIVE ATRIAL FIBRILLATION, COST-EFECTIVENESS, ANTICOAGULANT THERAPY AFTER NEW ONSET POST OPERATIVE ATRIAL FIBRILLATION
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20 MG Oral TabletDrug
Also called Rivaroxaban
After randomization, the patient will start medication (rivaroxaban 20mg per day or 15mg per day if eGFR between 30 and 50ml/min/1,73m²) within 24 hours. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued
WarfarinDrug
After randomization, the patient will start medication within 24 hours. Bridge with heparin or enoxaparin is recommended. The INR target is between 2,0 and 3,0. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban group | Experimental | After randomization, the patient will start medication (rivaroxaban 20mg per day or 15mg per day if eGFR between 30 and 50ml/min/1,73m²) within 24 hours. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued Receives: Drug: Rivaroxaban 20 MG Oral Tablet |
| Warfarin group | Experimental | After randomization, the patient will start medication within 24 hours. Bridge with heparin or enoxaparin is recommended. The INR target is between 2,0 and 3,0. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness between rivaroxaban and warfarin group
The primary outcome will be the cost-effectiveness, assessed by QALY, of the treatments in both therapeutic groups (rivaroxaban and warfarin) during the hospital stay with follow-up for 30 days after hospital discharge.
Measured: 30 days after hospital discharge
Secondary outcomes (2)
Bleeding according to ISTH bleeding score
Security outcome
Measured: 30 days after hospital discharge
Secondary outcome
(1) Death; (2) stroke; (3) MI; (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection;
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start5 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Vicente Serrano Jr, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300555
- Sponsor's protocol ID
- SDC 5074//20/103
- Acronym
- TASK-POAF
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05300555
- Acronym / sponsor ID
- TASK-POAF / SDC 5074//20/103
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- ANTICOAGULANTS, CORONARY ARTERY BYPASS GRAFT, ATRIAL FIBRILLATION, POST OPERATIVE ATRIAL FIBRILLATION, COST-EFECTIVENESS, ANTICOAGULANT THERAPY AFTER NEW ONSET POST OPERATIVE ATRIAL FIBRILLATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 29 Mar 2022 (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.
Coronary artery bypass graft (CABG) surgery is a common intervention in patients with coronary artery disease (CAD). The presence of new postoperative atrial fibrillation / atrial flutter (POAF) occurs in 15-40% of patients undergoing this procedure, with a high rate of complications, including increased hospital length of stay, with a consequent increase in the costs. In addition, the presence of POAF increases the rate of thromboembolic events such as stroke and mortality in the short and long term.
Anticoagulant treatment in patients with atrial fibrillation and atrial flutter (AF) lato sensu is already a well-established therapy in patients at high risk, defined by CHADS-VASC greater than or equal to 2. The use of direct-acting anticoagulants (DOACS) is standard therapy for those patients. In the POAF scenario, there is a recommendation for anticoagulation in high-risk patients for at least 30 days, however, despite being an entity with a poor prognosis in the short and long term, it is an undertreated entity. At present, there is no evidence of anticoagulant treatment of POAF with DOACS, and warfarin is the standard therapy. Warfarin is a drug that needs laboratory control of prothrombin time (PT) and anticoagulation bridge with other anticoagulants, usually using heparin and enoxaparin. We believe that because warfarin is the standard drug in this scenario, it is not prescribed on a regular basis, since it increases costs, length of hospital stay and is less effective than DOACS in AF lato sensu.
Thus, the research project intends to compare the cost-effectiveness, assessed by QALY, related to the warfarin prescription strategy associated with bridge anticoagulation versus the rivaroxaban prescription in patients who presented POAF with a minimum duration of 12 hours or AF that requires intervention. Medications will be started during hospitalization. After randomization, anticoagulant medication will be started within 24 hours. The patient will be reassessed in 30 days and if there is no evidence of maintenance of AF, the anticoagulant medication will be discontinued and the standard treatment for CAD will be maintained. Secondary outcomes will be: clinical outcomes, such as: (1) Death; (2) stroke; (3) myocardial infarction (MI); (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection. The safety outcome will be the bleeding assessment according to the bleeding score of the ISTH (International Society on Thrombosis and Haemostasis).
Considering that POAF is a prevalent entity and associated with a worse prognosis in the short and long term, as well as despite recommendations for guidelines to keep these patients anticoagulated, it is noted that the prescription of anticoagulation at hospital discharge is low. Considering that there is no clear evidence in studies on the use of DOAC in this population, we understand that the search for medications that lead to better cost-benefit, as well as better dosage and bleeding rates not lower than the use of warfarin, could lead to a higher rate prescribing anticoagulants for these patients, reducing costs, clinical and mortality outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban group | Experimental | Drug: Rivaroxaban 20 MG Oral TabletAfter randomization, the patient will start medication (rivaroxaban 20mg per day or 15mg per day if eGFR between 30 and 50ml/min/1,73m²) within 24 hours. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued |
| Warfarin group | Experimental | Drug: WarfarinAfter randomization, the patient will start medication within 24 hours. Bridge with heparin or enoxaparin is recommended. The INR target is between 2,0 and 3,0. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New atrial/flutter fibrillation / flutter lasting more than 12 hours in the postoperative period of CABG
- Individuals in both sex over the age of 18 years
Key exclusion criteria (6 listed)
- Inability to sign the free and informed consent form
- Contraindication to anticoagulant therapy
- Renal dysfunction with eGFR less than 30ml / min / 1.73m² or dialysis therapy
- Patients with previous AF
- Pregnancy
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 |
|---|---|---|
| Rivaroxaban 20 MG Oral TabletAlso: RivaroxabanAfter randomization, the patient will start medication (rivaroxaban 20mg per day or 15mg per day if eGFR between 30 and 50ml/min/1,73m²) within 24 hours. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued | Drug | Rivaroxaban group |
| WarfarinAfter randomization, the patient will start medication within 24 hours. Bridge with heparin or enoxaparin is recommended. The INR target is between 2,0 and 3,0. The medication will be prescribed up to 30 days after hospital discharge and if there is no clinical, electrocardiographic and Holter evidence of AF, the medication will be discontinued | Drug | Warfarin group |
Primary outcome
Cost-effectiveness between rivaroxaban and warfarin group
Time frame: 30 days after hospital discharge
The primary outcome will be the cost-effectiveness, assessed by QALY, of the treatments in both therapeutic groups (rivaroxaban and warfarin) during the hospital stay with follow-up for 30 days after hospital discharge.
2 secondary outcomes
Bleeding according to ISTH bleeding score
Time frame: 30 days after hospital discharge
Secondary outcome
Time frame: 30 days after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 20 MG Oral Tablet and Warfarin in people with Atrial Fibrillation New Onset, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 6 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 29 Mar 2022. 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 Brazil. 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 Eduardo Lima, Doctor (+55 11 26615352, eduglima@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness between rivaroxaban and warfarin group (time frame: 30 days after hospital discharge). 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 29 Mar 2022.