Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients (INTERMITTENT)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    100
  • sponsor
    University of Roma La Sapienza
Updated on 7 October 2022
coronary artery disease
atrial fibrillation
percutaneous coronary intervention
rivaroxaban
fibrillation
apixaban
edoxaban
electrocardiographic monitoring
dabigatran
chronic atrial fibrillation
anticoagulation therapy

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.

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.

Details
Condition Ischemic Heart Disease, Atrial Fibrillation
Treatment Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban, Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
Clinical Study IdentifierNCT04151680
SponsorUniversity of Roma La Sapienza
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

No chronic atrial fibrillation
Coronary artery disease
Percutaneous coronary intervention

Exclusion Criteria

Contraindications to anticoagulation
Pregnancy
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