To compare the duratin of double antiplatelets therapy after implant of new gereration medicated stent
- Conditions
- Coronary artery diseasesMedDRA version: 20.0Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-001834-25-IT
- Lead Sponsor
- ECRI-9
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4300
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
<20% by visual estimation
3) Free from any flow-limiting angiographic complications (i.e. significant
untreated dissection or major side-branch occlusion), which require prolonged
DAPT duration based on operator’s opinion.
4) All stages of PCI are complete (if any) and no further PCI is planned.
Inclusion criteria at one-month randomization visit
At randomization visit (one month after index PCI), the following criteria must be
met:
1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of
post-PCI actionable (i.e. requiring medical attention) non-access site related
bleeding episode
2) Uneventful 30-day clinical course, i.e. free from spontaneous MI,
symptomatic restenosis, stent thrombosis, stroke and any revascularization
(coronary and non-coronary) requiring prolonged DAPT
3) If not on OAC,
a. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
b. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no
switching between oral P2Y12 inhibitors has occurred in the previous
7 days)
4) If on OAC
a. Patient is on the same type of OAC (e.g. Vitamin K antagonist or
NOAC) for at least 7 days
b. Patient is on clopidogrel for at least 7 days
Definition of HBR
Post-PCI patients are at HBR if at least one of the following criteria applies:
¿ Clinical indication for treatment with oral anticoagulants (OAC) for at least 12
months
¿ Recent (<12 months) non-access site bleeding episode(s), which required
medical attention (i.e. actionable bleeding).
¿ Previous bleeding episode(s) which required hospitalization if the underlying
cause has not been definitively treated (i.e. surgical removal of the bleeding
source)
¿ Age equal or greater than 75 years
¿ Systemic conditions associated with an increased bleeding risk (e.g.
haematological disorders, including a history of or current thrombocytopaenia
defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known
coagulation disorder associated with increased bleeding risk.
¿ Documented anaemia defined as repeated haemoglobin levels <11 g/dl or
transfusion within 4 weeks before inclusion.
¿ Need for chronic treatment with steroids or non-steroidal anti-inflammatory
drugs
¿ Diagnosed malignancy (other than skin) considered at high bleeding risk
including gastro-intestinal, genito-urethral/renal and pulmonary.
¿ Stroke at any time or TIA in the previous 6 months
¿ PRECISE DAPT score of 25 or greater
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3870
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective is to compare, within current guidelines (GL) and instructions for use<br>(IFU), an abbreviated versus a prolonged DAPT duration after bioresorbable polymer<br>coated Ultimaster sirolimus-eluting stent implantation in patients presenting HBR<br>features.;Secondary Objective: Not Applicable;Primary end point(s): This study has 3 primary endpoints:<br>1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause<br>death, myocardial infarction, stroke and bleeding events defined as BARC 3 or<br>5<br>2) Major adverse cardiac and cerebral events (MACCE) defined as a composite<br>of all-cause death, myocardial infarction and stroke<br>3) Major or clinically relevant non-major bleeding (MCB) defined as a composite<br>of type 2, 3 and 5 BARC bleeding events;Timepoint(s) of evaluation of this end point: 11 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The individual components of each composite primary endpoints<br>2) The composite of cardiovascular death, MI, and stroke<br>3) The composite of cardiovascular death, MI, and any revascularization<br>4) Death from cardiovascular causes<br>5) The composite of definite or probable stent thrombosis<br>6) Myocardial infarction<br>7) Any target vessel revascularization<br>8) Urgent target vessel revascularization<br>Urgent non-target vessel revascularization<br>10) Clinically indicated non-target vessel revascularization<br>11) Bleeding events according to the BARC, TIMI and GUSTO classification<br>12) Transfusion rates both in patients with and/or without clinically detected overt<br>bleeding;Timepoint(s) of evaluation of this end point: 15 months