RE-DUAL TICLO PCI: Dual Therapy with dabigatran/ticagrelor versus Dual Therapy with dabigatran/clopidogrel in ACS patients with indication for NOAC undergoing PCI.
- Conditions
- acute coronary syndromAnticoagulantiapercutanous coronary intervention10011082
- Registration Number
- NL-OMON52203
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1000
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
• 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
• Heart valve prosthesis (mechanical) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> The primary endpoint is the first bleeding event (major and clinically<br /><br>relevant non-major), as defined by the Bleeding Academic Research Council<br /><br>(BARC) score >=2 in the 12 months follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p> The secondary endpoints are efficacy endpoints of thromboembolic events<br /><br>(myocardial infarction, stroke, systemic embolism) and death. Other secondary<br /><br>endpoints are a composite endpoint of thromboembolic events or death, as well<br /><br>as the individual thromboembolic events and stent thrombosis. </p><br>