Atrial Fibrillation Clinical Trial
Official title:
A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation
The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 30, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Get informed consent from the patient or family. 2. Non-valvular atrial fibrillation / atrial flutter. 3. The first transesophageal echocardiogram revealed a left atrial appendage thrombus (within 7 days of detection of thrombus). 4. Age at 18-80 years old. 5. CrCL= 30 mL/min (Cockcroft-Gault). 6. AST/ALT is less than 2 times the upper limit of normal. 7. Women of childbearing age need contraception. Exclusion Criteria: 1. Pregnant or lactating woman. 2. Can't understand or follow the research plan. 3. Patients under 18 or over 80 years old. 4. Low weight (< 40 kg). 5. Previously found LAA thrombus and have taken anticoagulant drugs. 6. Patients with contraindications for anticoagulation. 7. Patients who need to use antiplatelet drugs simultaneously within 6-12 months after ACS or PCI. 8. A history of cerebral hemorrhage. 9. Patients with active bleeding. 10. Severe gastritis, gastroesophageal reflux patients. 11. Combination of P-glycoprotein inhibitors and other drugs in the presence of NOAC contraindications. 13.Patient with tumor. 14.Planned surgery within 3 months. 15.Other investigators believe that patients are not suitable for enrollment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Second Affiliated Hospital of Chongqing Medical University |
Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, van Eickels M, Cohen A; X-TRA study and CLOT-AF registry investigators. Left atrial thrombus resolution in atrial fibrillation or flutter: Results of a prospective study with rivaroxaban (X-TR — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 3 to 6 weeks | Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 3rd, 6th week after initiation of anticoagulant therapy. | 6 weeks | |
Secondary | Number of patient who's thrombus in the left atrium or left atrial appendage is completely dissolved within 12 weeks | Transesophageal echocardiography was used to assess whether there was a left atrial appendage thrombus at 12th week after initiation of anticoagulant therapy. | 12 weeks | |
Secondary | Size change of left atrial appendage or left atrium thrombus | If a left atrial appendage or left atrial thrombus is detected,then the size of the thrombus is measured using echocardiography? | 12 weeks | |
Secondary | Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage. | Number of severe bleeding cases such as gastrointestinal bleeding and cerebral hemorrhage. | 12 weeks | |
Secondary | Number of transient ischemic attacks (TIA) and strokes | Number of transient ischemic attacks (TIA) and strokes | 12 weeks |
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