NCT06239402

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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,

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Observation	Observation of mortality, haemorrhagic and ischemic events in the studied population

Timeline

• Start date: 2020-07-28
• Primary completion: 2024-07-28
• Completion: 2024-07-28
• First posted: 2024-02-02
• Last updated: 2025-02-20

Locations

1 site across 1 country: Italy