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Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
For decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. This strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention.
Known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology.
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists.
The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent anticoagulation | Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode |
| |
| Chronic anticoagulation | Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban | Drug | Patients will receive intermittent treatment with a novel oral anticoagulant drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Outcome Event (MACE) | The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization | Up to 1 year |
| Days on anticoagulant treatment | The total number of days on anticoagulant treatment | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pelliccia, MD | Contact | +390649971 | f.pelliccia@mclink.it | |
| Giuseppe Marazzi, MD | Contact | +390649971 | euroheart@mclink.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Gaudio, MD | University Sapienza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Pisana | Recruiting | Rome | 00100 | Italy |
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|
| Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban | Drug | Patients will receive chronic treatment with a novel oral anticoagulant drug |
|
|
| Sapienza University | Recruiting | Rome | 00161 | Italy |
|
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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