Status:
RECRUITING
What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Acute Coronary Syndrome
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to pre...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years
- Undergoing successful PCI (either ACS or elective PCI)
- History of or newly diagnosed (\<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC
Exclusion
- Contra indication to edoxaban, aspirin or all P2Y12 inhibitors
- Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
- \<12 months after any stroke
- CHADSVASc score ≥7
- Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
- Mechanical heart valve prosthesis
- Intracardiac thrombus or apical aneurysm requiring OAC
- Poor LV function (LVEF \<30%) with proven slow-flow
- History of intracranial haemorrhage
- Active bleeding on randomization
- History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved
- Recent (\<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.
- Known coagulopathy
- Severe anaemia requiring blood transfusion or thrombocytopenia \<50 × 109/L
- BMI \>40 or bariatric surgery
- Kidney failure (eGFR \<15)
- Active liver disease (ALT, ASP, AP \>3x ULN or active hepatitis A, B or C)
- Active malignancy excluding non-melanoma skin cancer
- Life expectancy \<1 year
- Pregnancy or breast-feeding women
Key Trial Info
Start Date :
January 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04436978
Start Date
January 11 2023
End Date
December 1 2027
Last Update
December 15 2023
Active Locations (20)
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1
ASZ Aalst
Aalst, Belgium
2
UZ Antwerpen
Antwerp, Belgium
3
Imelda Ziekenhuis
Bonheiden, Belgium
4
UZ Brussel
Brussels, Belgium