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

Atrial Fibrillation Clinical Trial

— PRODOAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239402
• Other study ID #: 2365CE
• Status: Recruiting
• Start date: July 28, 2020
• Est. completion date: July 28, 2024

Study information

• Verified date: February 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 28, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Observation
Observation of mortality, haemorrhagic and ischemic events in the studied population

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Società Italiana Cardiologia Ospedalità Accreditata (SICOA)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding	Incidence of major bleeding and clinically relevant non major bleeding	3 months
Primary	Bleeding	Incidence of major bleeding and clinically relevant non major bleeding	12 months
Secondary	Adverse events	Cardiovascular events, death	3 months
Secondary	Adverse events	Cardiovascular events, death	12 months