Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease (PRODOAC)

Prospective Observational Study on the Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease (PRODOAC)

The study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy) and to analyze the outcomes of therapeutic decisions, focusing on mortality, hemorrhagic events, and ischemic events,

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Observation

Detailed Description

The combination of warfarin, aspirin, and clopidogrel represented the standard antithrombotic therapeutic strategy for patients with atrial fibrillation and suffering from acute coronary syndrome and/or undergoing percutaneous coronary intervention.

Current guidelines and clinical practice guides suggest the use of triple or dual antithrombotic therapy after a careful evaluation of the patient's hemorrhagic and thrombotic profile, without however providing indications with recommendation class I. It is not known what treatment regimens are prescribed in the real world, i.e. how clinicians behave in the absence of clear guidelines.

This observational study involves patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy), to describe the real-world prescription model used in clinical practice and to analyze the results of therapeutic choices in terms of mortality, hemorrhagic and ischemic events.

Patients are enrolled within 7 days from percutaneous coronary intervention during their hospitalization period. During the enrolment visit (i.e. baseline, T0), all patients undergo a detailed assessment of their medical history related to the recent hospitalization, laboratory blood analysis, and data related to their cardiovascular risk factors. Follow-up visits will be performed at three months (T3) and twelve months (T12). During the follow-up visit, any ischemic/bleeding events, therapeutic changes, and laboratory blood analysis will be recorded.

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Istituti Clinici Scientifici Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with non valvular atrial fibrillation with direct oral anticoagulants and antiplatelet therapy who underwent percutaneous coronary intervention in the previous 7 days

Description

Inclusion Criteria:

• Patient with non valvular atrial fibrillation with direct oral anticoagulants therapy
• Patient on antiplatelet therapy (acetylsalicylic acid and/or inhibitor of the P2Y12 platelet receptor)
• Patient hospitalized for percutaneous coronary intervention in the previous 7 days
• Age ≥18 years
• Estimated life expectancy ≥ 12 months
• Ability to give informed consent

Exclusion Criteria:

• Patients who have contraindications to direct oral anticoagulants therapy
• Patients who are indicated for direct oral anticoagulants therapy for reasons other than non valvular atrial fibrillation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Incidence of major bleeding and clinically relevant non major bleeding	3 months
Bleeding	Incidence of major bleeding and clinically relevant non major bleeding	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Cardiovascular events, death	3 months
Adverse events	Cardiovascular events, death	12 months

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Società Italiana Cardiologia Ospedalità Accreditata (SICOA)

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): July 28, 2024
• Study Completion (Actual): July 28, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Arrhythmias, Cardiac; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 2365CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No