The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.
The study objective is to determine in a high bleeding risk patient population undergoing PCI under standardized treatment (within current guidelines and instructions for use and including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months, whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within 12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB within 12 months. There are two treatment strategies: * abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, dual antiplatelet therapy is discontinued and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation) OR * prolonged dual anti-platelet therapy: aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation). In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Therefore either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation) The study design is an investigator-initiated, randomized, multi-center, clinical trial to be conducted in approximately 100 interventional cardiology centers in across the globe excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will occur at one month after the PCI procedure. The expected duration of participation for each patient is 14 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,579
Dosing per current guidelines and local practice
Dosing per current guidelines and local practice
Buenos Aires Research center
Buenos Aires, Argentina
Interventional Cardiology Sanatorio
Buenos Aires, Argentina
The Prince Charles Hospital
Chermside, Australia
St Vincents Hospital Melbourne
Melbourne, Australia
Research Center Perth
Perth, Australia
Research Center Sydney
Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
Time frame: 11 months
Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
Time frame: 11 months
Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Time frame: 11 months
All cause death
Time frame: 14 months
Death from cardiovascular causes
Time frame: 14 months
Myocardial infarction
Time frame: 14 months
Stroke
Time frame: 14 months
Bleeding events
Time frame: 14 months
Definite or probable stent thrombosis
Time frame: 14 months
Any target vessel revascularization
Time frame: 14 months
Urgent target vessel revascularization
Time frame: 14 months
Urgent non-target vessel revascularization
Time frame: 14 months
Clinically indicated non-target vessel revascularization
Time frame: 14 months
Transfusion rates both in patients with and/or without clinically detected over bleeding
Time frame: 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sydney, Australia
Wollongong Research Center
Wollongong, Australia
Research Center , 043-02
Vienna, Austria
Research Center, 043-01
Vienna, Austria
Research Centre Manama
Manama, Bahrain
...and 128 more locations