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Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG - PACeS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515924-35-00
Acronym
PACeS, final 3.0
Enrollment
750
Registered
2024-07-29
Start date
2023-01-16
Completion date
Unknown
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New-Onset Post-Operative Atrial Fibrillation after CABG

Brief summary

Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE)), Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5

Detailed description

Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism, Net clinical benefit (NCB), Incidence of the primary effectiveness and safety endpoints at 180 days after randomization, Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization, Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization, Incidence of BARC 2 bleeding at 90 and 180 days after randomization, Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization, Length of stay of index hospitalization, Number and reasons for readmissions at 90 and 180 days after rendomization, Hospital resource utilization at 180 days after surgey, Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization

Interventions

DRUGAspirin 500 mg überzogene Tabletten
DRUGClopidogrel ratiopharm 75 mg film-coated tablets
DRUGMarcumar 3 mg Tabletten

Sponsors

Icahn School Of Medicine At Mount Sinai
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE)), Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5

Secondary

MeasureTime frame
Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism, Net clinical benefit (NCB), Incidence of the primary effectiveness and safety endpoints at 180 days after randomization, Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization, Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization, Incidence of BARC 2 bleeding at 90 and 180 days after randomization, Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization, Length of stay of index hospitalization, Number and reasons for readmissions at 90 and 180 days after rendomization, Hospital resource utilization at 180 days after surgey, Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026