MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regime

Completed

Conditions: haert attack
HBR patienten
stent
10019280

Registration Number: NL-OMON50683

Lead Sponsor: European Cardiovascular Research Institute (ECRI-9) bv

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 550

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 <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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study has 3 primary endpoints:<br /><br>1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause<br /><br>death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5<br /><br>2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of<br /><br>all-cause death, myocardial infarction and stroke<br /><br>3) Major or clinically relevant non-major bleeding (MCB) defined as a composite<br /><br>of type 2, 3 and 5 BARC bleeding events<br /><br>The main analyses evaluate the occurrence of the primary endpoints between<br /><br>randomization and 11 months thereafter. In secondary analyses, the occurrence<br /><br>of primary endpoints between randomization and 15 months after index PCI is<br /><br>evaluated. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the study are the following:<br /><br>1) The individual components of each composite primary endpoints<br /><br>2) The composite of cardiovascular death, MI, and stroke<br /><br>3) The composite of cardiovascular death, MI, and any revascularization<br /><br>4) Death from cardiovascular causes<br /><br>5) The composite of definite or probable stent thrombosis<br /><br>6) Myocardial infarction<br /><br>7) Any target vessel revascularization<br /><br>8) Urgent target vessel revascularization<br /><br>9) Urgent non-target vessel revascularization<br /><br>10) Clinically indicated non-target vessel revascularization<br /><br>11) Bleeding events according to the BARC, TIMI and GUSTO classification<br /><br>12) Transfusion rates both in patients with and/or without clinically detected<br /><br>over bleeding</p><br>