Ignite Creation Date:
2024-05-06 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05936606
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-05-22
Brief Title:
Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients TAILOR-DAPT
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent DES placement However concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR high platelet reactivity who do not respond adequately to clopidogrel This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting
Detailed Description:
This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or an intervention group The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU platelet reactivity unit values The intervention group will receive personalized antiplatelet therapy based on their PRU values for non-HPR patients PRU208 clopidogrel monotherapy will be continued for HPR patients PRU208 dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients ischemicbleeding risk profiles Patients 50 years who presented with acute myocardial infarction at the time of coronary intervention and have high-risk characteristics ① 65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction will receive ticagrelor 60 mg twice daily with aspirin whereas the remainder will receive clopidogrel with aspirin For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patients risk profile The treatment assignment ratio is 11 The study period will be up to 24 months from the time of randomization
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