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NCT04688723CompletedPhase 4

REDUAL PCI Real Life Registry

RE-DUAL TICLO PCI: Dual Therapy with dabigatran/ticagrelor versus Dual Therapy with dabigatran/clopidogrel in ACS patients with indication for NOAC undergoing PCI.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1000 (actual)
First submitted
15 Oct 2024
Start date
16 Mar 2021
Lead sponsor
Zuyderland Medisch Centrum Stichting
NCT number
NCT04688723
EU CT number
2024-518666-27-00
EudraCT number
2020-005058-46

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 1000
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zuyderland Medisch Centrum Stichting
Coordinator of this site? Confirm its status
HeerlenNetherlandsCompleted
Academisch Ziekenhuis Maastricht
Coordinator of this site? Confirm its status
MaastrichtNetherlandsCompleted
Sint Antonius Ziekenhuis Stichting
Coordinator of this site? Confirm its status
NieuwegeinNetherlandsCompleted
Radboud universitair medisch centrum Stichting
Coordinator of this site? Confirm its status
NijmegenNetherlandsCompleted
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Coordinator of this site? Confirm its status
VenloNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.