A Phase 4 interventional study of Rivaroxaban 20 MG Oral Tablet and Warfarin in Atrial Fibrillation New Onset, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 50 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
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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
Drug: Rivaroxaban 20 MG Oral Tablet
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
Drug: Warfarin
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
Also known as: Rivaroxaban
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
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.
Time frame: 30 days after hospital discharge
Bleeding according to ISTH bleeding score
Security outcome
Time frame: 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;
Time frame: 30 days after hospital discharge
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University of Sao Paulo General Hospital