Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05117866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2021-09-16
Brief Title:
Acetyl Salicylic Elimination Trial JAPAN The ASET JAPAN Pilot Study
Sponsor:
Meditrix Corp
Organization:
Meditrix Corp
Study Overview
Official Title:
A Multicenter Single Arm Open-label Trial of Prasugrel Monotherapy After PCI With the SYNERGY Stent in Patients With Chronic Coronary Syndrome or Non-ST-elevation Acute Coronary Syndromes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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-JAPAN
Brief Summary:
The ASET Japan Pilot study is a multicenter single arm open-label trial of single antiplatelet therapy with prasugrel for patients undergoing successful and optimal Percutaneous Coronary Intervention PCI for Chronic Coronary Syndrome CCS and Non-ST elevation Acute coronary syndrome NSTE-ACS The enrollment consists of two phases i 200 patients presenting with CCS ii 200 patients presenting with NSTE-ACS The patients will be loaded with standard dual antiplatelet therapy according to local practice usually aspirin 81 to 330 mg and clopidogrel 300 mg or prasugrel 20 mg or ticagrelor 180 mg unless patient is on long-term therapy prior to the PCI procedure After PCI if the results are considered to be satisfactory by the operator based on clinical eg clinical status ECG etc angiographic andor findings from intracoronary imaging only then patients will be enrolled in the study and loaded with prasugrel 20 mg if the patients have not loaded prasugrel prior to PCI or have not taken a maintenance dose of prasugrel before the index PCI Patients continued with prasugrel only 375 mg once a day for three months in CCS patients and for 12 months in NSTE-ACS patients Aspirin clopidogrel and ticagrelor will be discontinued just after the index procedure
i CCS patients phase 1 At the 3-months follow-up visit prasugrel monotherapy will be replaced by aspirin monotherapy 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
ii NSTE-ACS patients phase 2 At the 12-months follow-up visit prasugrel monotherapy will be replaced by aspirin monotherapy for an observational period of 1 month followed by antiplatelet treatment according to local practice Clinical follow-up with office visit will be performed at 1 and 12 months and telephone contacts at 3 6 9 and 13 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 of CCS patients and up to 3 months follow-up of CCS patients and during enrollment of NSTE-ACS patients and up to 12 months follow-up of NSTE-ACS patients timepoint for primary endpoint
i CCS patients phase 1 At the 3-months follow-up visit prasugrel monotherapy will be replaced by aspirin monotherapy 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
ii NSTE-ACS patients phase 2 At the 12-months follow-up visit prasugrel monotherapy will be replaced by aspirin monotherapy for an observational period of 1 month followed by antiplatelet treatment according to local practice Clinical follow-up with office visit will be performed at 1 and 12 months and telephone contacts at 3 6 9 and 13 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 of CCS patients and up to 3 months follow-up of CCS patients and during enrollment of NSTE-ACS patients and up to 12 months follow-up of NSTE-ACS patients timepoint for primary endpoint
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None