Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03469856
Brief Summary:
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
Detailed Description:
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.
Study:
NCT03469856
Study Brief:
Protocol Section:
NCT03469856