search
Back to results

Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery (TASK-POAF)

Primary Purpose

Atrial Fibrillation New Onset

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rivaroxaban 20 MG Oral Tablet
Warfarin
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation New Onset focused on measuring ANTICOAGULANTS, CORONARY ARTERY BYPASS GRAFT, ATRIAL FIBRILLATION, POST OPERATIVE ATRIAL FIBRILLATION, COST-EFECTIVENESS, ANTICOAGULANT THERAPY AFTER NEW ONSET POST OPERATIVE ATRIAL FIBRILLATION

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Heart Institute - University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rivaroxaban group

Warfarin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Bleeding according to ISTH bleeding score
Security outcome
Secondary outcome
(1) Death; (2) stroke; (3) MI; (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection;

Full Information

First Posted
March 18, 2022
Last Updated
March 18, 2022
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05300555
Brief Title
Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery
Acronym
TASK-POAF
Official Title
Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban group
Arm Type
Experimental
Arm Description
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
Arm Title
Warfarin group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 20 MG Oral Tablet
Other Intervention Name(s)
Rivaroxaban
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
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
Primary Outcome Measure Information:
Title
Cost-effectiveness between rivaroxaban and warfarin group
Description
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.
Time Frame
30 days after hospital discharge
Secondary Outcome Measure Information:
Title
Bleeding according to ISTH bleeding score
Description
Security outcome
Time Frame
30 days after hospital discharge
Title
Secondary outcome
Description
(1) Death; (2) stroke; (3) MI; (4) Readmission; (5) Systemic embolization; (6); Surgical reintervention; (6) Bleeding using the ISTH score; (7) Infection;
Time Frame
30 days after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Lima, Doctor
Phone
+55 11 26615352
Email
eduglima@yahoo.com.br
Facility Information:
Facility Name
Heart Institute - University of São Paulo
City
São paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Lima, Doctor
Phone
+55 11 2661 5352
Email
eduglima@yahoo.com.br

12. IPD Sharing Statement

Learn more about this trial

Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery

We'll reach out to this number within 24 hrs