haert attack HBR patienten stent
Conditions
Interventions
One group of patients will receive after placement of the stent a shorter
treatment with anti-coagulant medication
the other group will receive a longer
treatment with anti-coagulant medication.
Sponsors
European Cardiovascular Research Institute (ECRI-9) bv
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria after index PCI After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met. 1) At least one among the HBR criteria (as defined below) is met. 2) All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis
Exclusion criteria
Exclusion criteria: Patients are not eligible if any of the following applies 1) Treated with stents other than Ultimaster stent within 6 months prior to index procedure 2) Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before 3) Treated with a bioresorbable scaffold at any time prior to index procedure 4) Cannot provide written informed consent 5) Under judicial protection, tutorship or curatorship 6) Unable to understand and follow study-related instructions or unable to comply with study protocol 7) Active bleeding requiring medical attention (BARC>=2) on randomization visit 8) Life expectancy less than one year 9) Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus 10) Any planned and anticipated PCI 11) Participation in another trial 12) Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study has 3 primary endpoints: 1) 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 2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke 3) Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are the following: 1) The individual components of each composite primary endpoints 2) The composite of cardiovascular death, MI, and stroke 3) The composite of cardiovascular death, MI, and any revascularization 4) Death from cardiovascular causes 5) The composite of definite or probable stent thrombosis 6) Myocardial infarction 7) Any target vessel revascularization 8) Urgent target vessel revascularization 9) Urgent non-target vessel revascularization 10) Clinically indicated non-target vessel revascularization 11) Bleeding events according to the BARC, TIMI and GUSTO classification 12) Transfusion rates both in patients with and/or without clinically detected over bleeding | — |
Countries
Netherlands
Outcome results
None listed