Istituti Clinici Scientifici Maugeri
Milan, Italy
NCT Number: NCT06239402
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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Notify Me18 year and older
All sexes
Observational
Milan, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observation of mortality, haemorrhagic and ischemic events in the studied population
Time frame: 3 months
Incidence of major bleeding and clinically relevant non major bleeding
Time frame: 12 months
Incidence of major bleeding and clinically relevant non major bleeding
Time frame: 3 months
Cardiovascular events, death
Time frame: 12 months
Cardiovascular events, death
Istituti Clinici Scientifici Maugeri SpA
Other
Prospective Observational Study on the Therapeutic Strategy with Direct Oral Anticoagulants and Antiaggregant Drugs in Ischemic Heart Disease (PRODOAC)
Acronym: PRODOAC
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