Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648720
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHORTDAPT
Brief Summary:
This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy DAPT at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention PCI guided by intravascular ultrasound IVUS The main outcomes measured will include major adverse cardiovascular and cerebrovascular events NACCE bleeding events and target vessel failure TVF The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding
Detailed Description:
This multicenter double-blind randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months in patients who have undergone PCI with drug-eluting stent DES implantation The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications Intravascular ultrasound IVUS will be used to guide stent placement and optimize results especially in high-risk complex cases
Participants will be randomly assigned to two groups
1 One month of DAPT followed by monotherapy with a P2Y12 inhibitor
2 Standard 12 months of DAPT Patients will be followed for 12 months after the intervention to track cardiovascular events bleeding complications and overall safety
Participants will be randomly assigned to two groups
1 One month of DAPT followed by monotherapy with a P2Y12 inhibitor
2 Standard 12 months of DAPT Patients will be followed for 12 months after the intervention to track cardiovascular events bleeding complications and overall safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None