Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation Clinical Trial
Official title:
AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.
| Status | Recruiting |
| Enrollment | 840 |
| Est. completion date | October 2028 |
| Est. primary completion date | July 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility | Inclusion Criteria: 1. no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation 2. CHA2DS2-VASc score >=1 (male) or >=2 (female) 3. age: 19 to 80 years 4. non-valvular atrial fibrillation 5. those who consent the study. 6. those who can be followed after enrollment Exclusion Criteria: 1. Severe liver or kidney dysfunction 2. Thyroid dysfunction 3. Pregnant or breastfeeding women 4. Malignant tumors that have not been completely cured 5. Severe structural heart disease 6. Predicted survival is less than 12 months 7. Patients who do not understand the content of the study or disagree with it |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance Cardiovascular Hospital Yonsei University | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | Baseline | |
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | 1 month | |
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | 6 months | |
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | 12 months | |
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | 18 months | |
| Primary | Composite outcome | composite outcome including stroke/systemic embolism and major bleeding | 24 months | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | Baseline | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | 1 month | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | 6 months | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | 12 months | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | 18 months | |
| Secondary | Stroke | Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage. | 24 months | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
Baseline | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
1 month | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
6 months | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
12 months | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
18 months | |
| Secondary | Major bleeding | The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms.
1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. |
24 months | |
| Secondary | Clinically Relivant Non-Major Bleeding (CRNMB) | - Clinically Relivant Non-Major Bleeding (CRNMB) :
Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: |
Baseline, 1month, 6 month, 12 month, 18 month, 24 month | |
| Secondary | Death | Death: the permanent stopping of all the vital bodily activities | Baseline, 1month, 6 month, 12 month, 18 month, 24 month | |
| Secondary | Transient ischemic attack (TIA) | TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction. | Baseline, 1month, 6 month, 12 month, 18 month, 24 month | |
| Secondary | Hospital admission | Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury. | Baseline, 1month, 6 month, 12 month, 18 month, 24 month |