Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
NCT ID: NCT04151680
Last Updated: 2022-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-12-01
2023-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Intermittent anticoagulation
Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode
Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive intermittent treatment with a novel oral anticoagulant drug
Chronic anticoagulation
Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring
Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive chronic treatment with a novel oral anticoagulant drug
Interventions
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Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive intermittent treatment with a novel oral anticoagulant drug
Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Patients will receive chronic treatment with a novel oral anticoagulant drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Coronary artery disease
* Percutaneous coronary intervention
Exclusion Criteria
* Pregnancy
18 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Pelliccia
Professor
Principal Investigators
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Carlo Gaudio, MD
Role: STUDY_DIRECTOR
University Sapienza
Locations
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San Raffaele Pisana
Rome, , Italy
Sapienza University
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019/D/983
Identifier Type: -
Identifier Source: org_study_id
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