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

Recruiting

• Conditions: Atrial Fibrillation; Ischemic Heart Disease
• Interventions: Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban; Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban

• Registration Number: NCT04151680
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Study Start: 2019-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-09
• Primary Completion: 2022-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Contraindications to anticoagulation
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic anticoagulation	Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban	Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring
Intermittent anticoagulation	Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban	Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

San Raffaele Pisana; 🇮🇹 Rome, Italy

Sapienza University; 🇮🇹 Rome, Italy