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REDUAL PCI Real Life Registry
EU CTIS ID: 2024-518666-27-00
What this study is testing
A real world registry based Randomised controlled trial to compare dual therapy with Dabigatran/Ticagrelor to Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS.
- Phase III and phase IV (Integrated)
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
- In order to be eligible to participate in this study, the investigator should have carefully considered participation of the patient after extensively consideration between high risk of bleeding and risk of thromboembolic events. Furthermore, a subject must meet all of the following criteria: • Age ≥ 18 years • PCI and successful stenting with a Drug Eluting Stent (DES) • Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Patients with permanent, persistent or paroxysmal atrial fibrillation are eligible. • Written informed consent. In addition to the inclusion criteria above, all patients should meet one of the following conditions: • Admission to the hospital with ACS (unstable angina, NSTEMI, STEMI) • High risk PCI as defined by the presence of one of the following conditions: o Chronic Total Occlusion o Two-stent bifurcation laesion o Total stent length of >60mm in initial procedure o Venous graft stenting • Or the presence of medically treated type I or II diabetes mellitus
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study: • Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study • Glomerular filtration rate < 30 ml/min • Prior or planned mechanical heart valve prosthesis. Patients with (planned) Transcatheter Aortic Valve Implantation or Aortic Valve Replacement with bioprosthetic valve, are eligible for participation in this study. • Cardiogenic shock • Contra-indication for Dabigatran, Ticagrelor or Clopidogrel o Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C) o Lesion or condition with a significant risk of serious bleeding, such as: current or recent gastrointestinal ulceration; malignant neoplasms with more bleeding risk; recent brain / spinal cord injury; recent surgery on the brain, spinal cord or eyes; recent or history of intracranial haemorrhage; oesophageal varices; arteriovenous malformations; vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities. o comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan’s wort or phenytoin o Comedication with tacrolimus is not recommended. • Allergy to for Dabigatran, Ticagrelor or Clopidogrel • Pregnancy • Significant thrombocytopenia (platelet count < 50x10 9/L) • Major bleeding according to BARC ≥3 within the past 6 months. • Weight < 50 kg
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.