BridgeMD
WOEST-3
EU CTIS ID: 2022-502140-13-00
What this study is testing
1. To assess bleeding risk (i.e. safety) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF. 2. To assess ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age
- Undergoing successful 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 (e.g. kidney failure (eGFR <15) or allergy)
- Life expectancy <1 year
- Other oral anticoagulation than NOAC or acenocoumarol at randomization (e.g. fenprocoumon)
- Active malignancy with metastases or non-curative treatment (e.g. palliative chemotherapy)
- Known coagulopathy
- Active bleeding on randomization
See the full eligibility criteria
- ≥18 years of age
- Undergoing successful 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 (e.g. kidney failure (eGFR <15) or allergy)
- Life expectancy <1 year
- Other oral anticoagulation than NOAC or acenocoumarol at randomization (e.g. fenprocoumon)
- Active malignancy with metastases or non-curative treatment (e.g. palliative chemotherapy)
- Known coagulopathy
- 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.
- Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 10^9/L
- Pregnancy or breast-feeding women
- BMI >40 or bariatric surgery
- Poor LV function (LVEF <30%) with proven slow-flow
- <12 months after any stroke
- CHA2DS2VASc score ≥7
- Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism, mechanical heart valve prosthesis, intracardiac thrombus or apical aneurysm requiring OAC)
- History of intracranial haemorrhage
- Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
- Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.