Phase
Condition
Myocardial Ischemia
Thrombosis
Stroke
Treatment
30-day DAPT
Guideline-directed therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients ≥ 18 years
- Undergoing successful PCI (either ACS or elective PCI)
- History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutterwith a long-term (≥ 1 year) indication for OAC
Exclusion
Exclusion Criteria:
- Contra indication to edoxaban, aspirin or all P2Y12 inhibitors
- Current indication for OAC besides atrial fibrillation/flutter (e.g. venousthromboembolism)
- <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-articularbleeding, unless the causative factor has been permanently resolved
- Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has beenpermanently 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
Study Design
Connect with a study center
ASZ Aalst
Aalst,
BelgiumActive - Recruiting
UZ Antwerpen
Antwerpen,
BelgiumActive - Recruiting
Imelda Ziekenhuis
Bonheiden,
BelgiumActive - Recruiting
UZ Brussel
Brussel,
BelgiumActive - Recruiting
Ziekenhuis Oost-Limburg
Genk,
BelgiumActive - Recruiting
AZ Maria Middelares Gent
Gent,
BelgiumActive - Recruiting
Jan Yperman
Ieper,
BelgiumSite Not Available
AZ Groeninge
Kortrijk,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumActive - Recruiting
AZ Delta
Roeselare,
BelgiumActive - Recruiting
Noordwest Ziekenhuisgroep
Alkmaar,
NetherlandsActive - Recruiting
Amsterdam UMC
Amsterdam,
NetherlandsActive - Recruiting
OLVG
Amsterdam,
NetherlandsActive - Recruiting
Hagaziekenhuis
Den Haag,
NetherlandsActive - Recruiting
Catharina Ziekenhuis
Eindhoven,
NetherlandsActive - Recruiting
Treant Zorggroep
Emmen,
NetherlandsActive - Recruiting
Zuyderland Ziekenhuis
Heerlen,
NetherlandsSite Not Available
Tergooi MC
Hilversum,
NetherlandsActive - Recruiting
St. Antonius Hospital
Nieuwegein,
NetherlandsActive - Recruiting
Elisabeth Tweesteden Ziekenhuis
Tilburg,
NetherlandsActive - Recruiting
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