Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients
NCT06648720 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3566
Last updated 2024-10-18
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.
Conditions
- Coronary Arterial Disease (CAD)
- Percutaneous Coronary Intervention (PCI)
- Intravascular Ultrasound
- Dual Antiplatelet Therapy
Interventions
- DRUG
-
DAPT de-escalation
Patients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months.
Sponsors & Collaborators
-
University of Medicine and Pharmacy at Ho Chi Minh City
collaborator OTHER -
University Medical Center Ho Chi Minh City (UMC)
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2028-03-01
- Completion
- 2029-03-01
Countries
- Vietnam
Study Locations
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