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

Atrial Fibrillation Clinical Trial

— INTERMITTENT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151680
• Other study ID #: 2019/D/983
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2022
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD
• Phone: +390649971
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindications to anticoagulation
• Pregnancy

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	San Raffaele Pisana	Rome
Italy	Sapienza University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Outcome Event (MACE)	The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia driven revascularization	Up to 1 year
Primary	Days on anticoagulant treatment	The total number of days on anticoagulant treatment	Up to 1 year