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OpenTrials
Completed

NCT Number: NCT06239402

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

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,

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Bleeding

    Time frame: 3 months

    Incidence of major bleeding and clinically relevant non major bleeding

  2. Bleeding

    Time frame: 12 months

    Incidence of major bleeding and clinically relevant non major bleeding

Secondary outcomes

  1. Adverse events

    Time frame: 3 months

    Cardiovascular events, death

  2. Adverse events

    Time frame: 12 months

    Cardiovascular events, death

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Società Italiana Cardiologia Ospedalità Accreditata (SICOA)

Registry information

Official study title

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

Acronym: PRODOAC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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