Monotherapy After PCI Clinical Trial
Official title:
ASET Clinical Investigational Plan Acetyl Salicylic Elimination Trial: The ASET Pilot Study
A multicenter, single arm, open-label trial of prasugrel monotherapy after PCI with the new-generation thin-strut biodegradable polymer everolimus-eluting SYNERGY® stent in patients with chronic stable angina
Single antiplatelet therapy with prasugrel is safe in selected patients undergoing successful
PCI with the new generation biodegradable polymer everolimus-eluting SYNERGY® stent.
To assess in a proof-of-concept study the safety of single antiplatelet therapy with
prasugrel after PCI with a new generation biodegradable polymer drug eluting stent in terms
of ischemic and bleeding outcomes.
The ASET Pilot study is a multicenter, single arm, open-label trial of single antiplatelet
therapy with prasugrel for patients undergoing successful and optimal PCI for chronic stable
angina with normal cardiac biomarkers values. The patients will be loaded with standard dual
antiplatelet therapy according to local practice (usually aspirin 300 mg and clopidogrel 600
mg, unless patient is on long-term therapy) at least 2 hours prior to the diagnostic
catheterization or PCI procedure. After PCI, if the results are considered to be satisfactory
by the operator based on clinical (e.g. clinical status, ECG, etc.), angiographic and/or
findings from intracoronary imaging, only then patients will be enrolled in the study and
loaded with prasugrel 60 mg and continued with prasugrel only (10 mg once a day) for three
months. Aspirin and clopidogrel will be discontinued. At the 3-months follow-up visit,
prasugrel (only) will be replaced by aspirin (only) or dual-antiplatelet therapy according to
local standard of care. Clinical follow-up with office visit will be performed at 3 months
and telephone contacts at 1, and 4 months (final follow-up). All events will be adjudicated
by an independent clinical events committee (CEC).
An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and
collective safety of the patients in the study during enrolment phase and up to 3 months
follow-up (primary endpoint).
The ASET study is a proof-of-concept pilot, feasibility and safety study designed as a single
arm, open label trial with a stopping rule based on the occurrence of definite stent
thrombosis. Based on previous pilot studies, 200 patients will be enrolled. The trial will be
terminated if more than three (>3) patients experience definite stent thrombosis following
index procedure till 4 months follow-up.
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