Clinical trial NCT04151680: Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
Official title: Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Disease
Atrial Fibrillation
Keywords: coronary artery disease
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindications to anticoagulation
* Pregnancy

Primary outcomes:
measure: Major Adverse Outcome Event (MACE)
timeFrame: Up to 1 year
measure: Days on anticoagulant treatment
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Raffaele Pisana
city: Rome
country: Italy
facility: Sapienza University
Study officials:
affiliation: University Sapienza
name: Carlo Gaudio, MD
role: STUDY_DIRECTOR
References: