Atrial Fibrillation, Ischemic Heart Disease
Conditions
Keywords
coronary artery disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive intermittent treatment with a novel oral anticoagulant drug
DRUGChronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive chronic treatment with a novel oral anticoagulant drug
Sponsors
University of Roma La Sapienza
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* No chronic atrial fibrillation * Coronary artery disease * Percutaneous coronary intervention
Exclusion criteria
* Contraindications to anticoagulation * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Outcome Event (MACE) | Up to 1 year | The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization |
| Days on anticoagulant treatment | Up to 1 year | The total number of days on anticoagulant treatment |
Countries
Italy
Contacts
Primary ContactFrancesco Pelliccia, MD
Backup ContactGiuseppe Marazzi, MD
Outcome results
None listed