The objective is to compare, within current guidelines (GL) and instructions for use (IFU), an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting HBR…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
High bleeding risk population represents a significant proportion of coronary
artery disease (CAD) patients undergoing coronary stent implantation. Decisions
regarding the duration of dual antiplatelet therapy (DAPT) after stent
implantation are difficult, especially after implantation of newer generation
drug eluting stents (DES) due to conflicting results from recent trials.
The current ESC guidelines of myocardial revascularization indicate that in
patients at high bleeding risk (HBR), shorter DAPT duration (<6 months) might
be considered after DES implantation (Class of recommendation: IIb). Similarly,
the more recent American guidelines on DAPT duration, stated that in patients
treated with DAPT after DES implantation who develop a high risk of bleeding
(e.g., treatment with oral anticoagulant therapy), are at high risk of severe
bleeding complication (e.g., major intracranial surgery), or develop
significant overt bleeding, discontinuation of P2Y12 inhibitor therapy after 3
or 6 months may be reasonable (Class of recommendation IIb). Both the European
and American guidelines acknowledge that limited data is currently available to
sustain this practice and call for dedicated DAPT studies in HBR patients.
Therefore, further randomized trials are needed to appraise the optimal DAPT
duration in HBR patients treated with contemporary DES.
Study objective
The objective is to compare, within current guidelines (GL) and instructions
for use (IFU), an abbreviated versus a prolonged DAPT duration after
bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in
patients presenting HBR features.
Study design
Een onderzoeker-geïnitieerd, multi center, gerandomiseerde klinische proef in
HBR patiënten na PCI, met Ultimaster bioresorbable polymeer sirolimus-eluerende
gecoate stent implantatie.
Intervention
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.
Study burden and risks
To improve patient standard care, there will be 3 point of contacts 1 on site
visit during which the medication regime, anginaal status and adverse events
are discussed and monitored.
Westblaak 98, ingang B 98
Rotterdam 3012 KM
NL
Westblaak 98, ingang B 98
Rotterdam 3012 KM
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59979.101.16 |