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

Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation

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 Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Ischemic Heart Disease
• Intervention / Treatment: Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban; Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Francesco Pelliccia, MD; Phone Number: +390649971; Email: f.pelliccia@mclink.it
• Study Contact Backup: Name: Giuseppe Marazzi, MD; Phone Number: +390649971; Email: euroheart@mclink.it

Study Locations

• Italy
  • Rome, Italy, 00100
    • Recruiting
    • San Raffaele Pisana
  • Rome, Italy, 00161
    • Recruiting
    • Sapienza University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High bleeding risk (HBR) patients undergoing percutaneous coronary angiography with history of paroxysmal atrial fibrillation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindications to anticoagulation
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intermittent anticoagulation; Patients receiving anticoagulation only if continuous electrocardiographic monitoring detects an atrial fibrillation episode	Drug: Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban; Patients will receive intermittent treatment with a novel oral anticoagulant drug; Other Names: INTERMITTENT GROUP
Chronic anticoagulation; Patients receiving chronic oral anticoagulation regardless findings at continuous electrocardiographic monitoring	Drug: Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban; Patients will receive chronic treatment with a novel oral anticoagulant drug; Other Names: CHRONIC GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Days on anticoagulant treatment	The total number of days on anticoagulant treatment	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Study Director: Carlo Gaudio, MD, University Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: coronary artery disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban; Edoxaban
• Other Study ID Numbers: 2019/D/983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No