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

NCT06239402 | Completed

• 1 other identifier: 2365CE
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

Brief 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,

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse events

  3 months

• Adverse events

  12 months

Interventions

Observation OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Società Italiana Cardiologia Ospedalità Accreditata (SICOA): collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Observation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: July 28, 2020
• Primary Completion: July 28, 2024
• Study Completion: July 28, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)