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The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC.
The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolism, or device-related thrombosis. This antithrombotic strategy was subsequently endorsed by the guidelines, briefly, patients with LAAO were discharged on warfarin and aspirin for 45 days post-LAAO, if there was no leak or a leak ≤5 mm under transesophageal echocardiography (TEE) at 45-day follow-up, antithrombotic strategies shall switch to dual antiplatelet therapy (DAPT) until 6 months post-LAAO, and then aspirin thereafter.
Although LAAO was recommended by medical societies, previous patient-level meta-analyses have implied that compared with oral anticoagulation, LAAO had significantly more ischemic strokes, suggesting the inability of LAAO to prevent an ischemic stroke from sources beyond LAA. Will a combined strategy of LAAO and OAC further reduce the risk of stroke? The investigators hypothesized that a long-term low dose-Rivaroxaban (10mg daily) post-LAAO might be a potent supplement to the residue risk of ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose novel oral anti-coagulation (NOAC)-based anti-thrombotic therapy | Experimental | HAS-BLED<3: Rivaroxaban 15 mg QD for 3 months, followed by Rivaroxaban 10 mg QD indefinitely HAS-BLED≥3: Rivaroxaban 10 mg QD for 3 months, followed by Rivaroxaban 2.5 mg bid indefinitely |
|
| Guideline determined medication therapy (GDMT) | Active Comparator | HAS-BLED<3: Rivaroxaban 15 mg QD + Aspirin 100mg QD for 3 months, then Aspirin 100mg QD indefinitely HAS-BLED≥3: Aspirin 100mg QD + Clopidogrel 75mg QD for 3 months, then Aspirin 100mg QD indefinitely |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 15mg | Drug | QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of the composite endpoint of any death, any stroke, systemic embolism, and The Bleeding Academic Research Consortium (BARC)-defined 3 or 5 bleeding events | 24 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of the composite endpoint of any death, any stroke, systemic embolism, and BARC defined 3 or 5 bleeding events | 45 days, 6, 12 months (Time-to-event) | |
| Rate of the composite endpoint of any death, any stroke, systemic embolism | 45 days, 6, 12, 24 months (Time-to-event) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Gao, M.D., Ph.D. | Contact | +86-18629551066 | woshigaochao@gmail.com | |
| Ruining Zhang, BSc | Contact | +86-15802990370 | ruining-zhang@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, M.D., Ph.D. | Xijing Hospital | Study Chair |
| Chao Gao, M.D., Ph.D. | Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ling Tao | Recruiting | Xi'an | Shannxi | 710032 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Aspirin 100mg | Drug | QD |
|
| Clopidogrel 75mg | Drug | QD |
|
| Rivaroxaban 10mg | Drug | QD |
|
| Rivaroxaban 2.5mg | Drug | B.I.D |
|
| Rate of the BARC type 3 or 5 bleeding events | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of the composite endpoint of any death, any stroke, systemic embolism, myocardial infarction (MI) | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of any death | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of any stroke | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of systemic embolism | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of myocardial infarction (MI) | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of BARC type 2, 3 or 5 bleeding events | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of BARC type 2 bleeding events | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of BARC type 3 bleeding events | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of BARC type 5 bleeding events | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of GUSTO defined major bleeding and/or minor bleeding | Global Use of Strategies to Open Occluded Arteries, (GUSTO) defined major bleeding and/or minor bleeding | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of TIMI defined major bleeding and/or minor bleeding | Thrombolysis in Myocardial Infarction (TIMI) defined major bleeding and/or minor bleeding | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of ISTH defined major bleeding and/or clinically relevant minor bleeding | International Society on Thrombosis and Haemostasis (ISTH) defined major bleeding and/or clinically relevant minor bleeding | 45 days, 6, 12, 24 months (Time-to-event) |
| Rate of patient adherence to allocated medication | Adherence is defined as the participant who uses the medication strategies in this trial achieving 80% of the time on the therapeutic range | 45 days, 6, 12, 24 months (Binary) |
| Scores of the National Institutes of Health Stroke Scale (NIHSS) questionnaire | The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. | 45 days, 6, 12, 24 months (Continuous) |
| Scores of the Modified Rankin Scale (mRS) | The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. | 45 days, 6, 12, 24 months (Continuous) |
| Scores of the 5-level EQ-5D version (EQ-5D-5L) questionnaire | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 45 days, 6, 12, 24 months (Continuous) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |