The primary objective of this study is to assess the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to, during and after PCI with a new generation drug-eluting in non-ST-elevation acute coronary syndrome…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary ischemic endpoints at 6 months is the composite of:
- All-cause mortality
- Myocardial infarction (according to the 4th universal definition of MI)
- Academic Research Consortium (ARC) defined definite or probable stent
thrombosis
- Ischemic stroke
The primary bleeding endpoint at 6 months is:
- Major or minor bleeding defined as Bleeding Academic Research Consortium
(BARC) type 2, 3 or 5 bleeding
Secondary outcome
The secondary endpoints are:
- Primary ischemic and bleeding endpoint at 12 months
- Each individual component of the primary endpoints at 6 and 12 months
- Cardiovascular mortality at 6 and 12 months
- Non-cardiovascular mortality at 6 and 12 months
- Any need for revascularization at 6 and 12 months
- Any periprocedural complications
- On-treatment platelet reactivity at baseline
Background summary
Approximately 15,000 patients with non-ST-segment elevation acute coronary
syndrome (NSTE-ACS) are admitted to Dutch hospitals each year. Most of these
patients are treated with percutaneous coronary intervention (PCI) using
intracoronary stents. Dual antiplatelet therapy (DAPT), consisting of aspirin
and a P2Y12-inihibitor, reduces the risk of stent thrombosis, myocardial
infarction (MI) and stroke as compared to aspirin alone after coronary stent
implantation. However, DAPT inevitably increases the risk of major bleeding
events, which in turn is associated with increased mortality, morbidity and
reduced quality of life (all associated with very high healthcare costs). In
recent decades, improvements in stent designs, interventional techniques and
antithrombotic therapies have substantially reduced the risk of stent
thrombosis and subsequent ischemic complications.
Among these improvements is the development of new generation drug-eluting
stents (DES). The bulky, thick-strut bare-metal stents (BMS) that were used
when DAPT was introduced, have therefore become obsolete. The advent of safer,
new generation DES equipped with biocompatible coatings has led to low rates of
stent thrombosis. These DES are now commonly used in all patients.
Pharmacological therapy has improved as well. New potent P2Y12-inhibitors, i.e.
prasugrel and ticagrelor, have been shown to significantly reduce the incidence
of stent thrombosis as compared to clopidogrel. These novel agents are
currently used alongside aspirin as the standard-of-care for acute coronary
syndrome (ACS).
These combined innovations in the field of interventional cardiology have
opened the door for single antiplatelet strategies. Previous randomized
controlled trials (RCT) have already shown the effects of a single antiplatelet
strategy with potent P2Y12-inhibitors, but this always involved concurrent
aspirin use during at least 1-3 months. A recent meta-analysis of four trials
investigating P2Y12-inhibitor monotherapy after PCI concluded that
P2Y12-inhibitor monotherapy preceded by a short period of DAPT was associated
with a lower incidence of clinically relevant bleeding compared to standard
DAPT without a significant differences in cardiovascular events after one year.
Study objective
The primary objective of this study is to assess the feasibility and safety of
a single antiplatelet strategy with prasugrel or ticagrelor prior to, during
and after PCI with a new generation drug-eluting in non-ST-elevation acute
coronary syndrome patients
Study design
Single-center, single-arm pilot study
Intervention
Prasugrel or ticagrelor monotherapy prior to, during and 12 months after
percutaneous coronary intervention
Study burden and risks
In addition to standard care, patients will undergo platelet function testing
with VerifyNow prior to the procedure, which requires an additional blood draw.
Furthermore, the first 35 patients will undergo optical coherence tomography
assessment after stent implantation. Patients will be contacted by phone at 1,
3, 6 and 12 month(s) after stent implantation for follow-up. Single
antiplatelet therapy may lead to a reduction in (major) bleeding events, while
reducing the number of medications patients use. However, it is unknown if
single antiplatelet therapy effects the risk of thrombotic complications (e.g.
stent thrombosis).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years
- NSTE-ACS diagnosis in accordance with relevant guidelines
- *De novo* coronary lesion(s) eligible for PCI using new generation
drug-eluting stent and requiring revascularization according to relevant
guidelines
- Written informed consent
Exclusion criteria
- Known allergy or contraindication for prasugrel or ticagrelor use
- Concurrent use of oral anticoagulants (e.g. for atrial fibrillation)
- Overwriting indication for DAPT (e.g. recent PCI or ACS)
- Planned surgical intervention within 12 months of planned
revascularization
- PCI of left main disease, chronic total occlusion, bifurcation lesion
requiring two-stent treatment, saphenous or arterial graft lesion, severely
calcified lesions
- Recent or ongoing treatment with a strong CYP3A4 inhibitor or inducer
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device (i.e.
stent)
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-003437-38-NL |
| ClinicalTrials.gov | NCT04766437 |
| CCMO | NL74724.018.20 |