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

University of Roma La Sapienza

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Heart Disease; Atrial Fibrillation

Treatments: Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban; Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban

Study type: Observational

Funder types: Other

Identifiers

NCT04151680

2019/D/983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No chronic atrial fibrillation
• Coronary artery disease
• Percutaneous coronary intervention

Exclusion criteria

• Contraindications to anticoagulation
• Pregnancy

Trial design

100 participants in 2 patient groups

Intermittent anticoagulation

Description:

Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode

Treatment:

Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban

Chronic anticoagulation

Description:

Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring

Treatment:

Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban