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New treatment option for Acute Coronary Syndrome
Official title What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?
ClinicalTrials.gov ID: NCT04436978
What this study is testing
What is 30-day DAPT?
30-day DAPT is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute coronary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 flutter with a long-term (≥ 1 year) indication for OAC
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Antwerp, Belgium
- Bonheiden, Belgium
- Brussels, Belgium
- Genk, Belgium
- Ghent, Belgium
- Ieper, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Alkmaar, Netherlands
- Amsterdam, Netherlands
- Eindhoven, Netherlands
- Emmen, Netherlands
- Heerlen, Netherlands
- Hilversum, Netherlands
- Nieuwegein, Netherlands
- The Hague, Netherlands
- Tilburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Antwerp, Belgium; Bonheiden, Belgium; Brussels, Belgium; Genk, Belgium; Ghent, Belgium and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.