Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT03469856
Status:
UNKNOWN
Last Update Posted:
2018-03-19
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acetyl Salicylic Elimination Trial: The ASET Pilot Study
Sponsor:
Pedro A. Lemos
Organization:
Study Overview
Official Title:
ASET Clinical Investigational Plan Acetyl Salicylic Elimination Trial: The ASET Pilot Study
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASET
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: