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| Name | Class |
|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group) | Experimental | 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. |
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| Group 2 (12-Month DAPT): Standard DAPT (Control Group) | No Intervention | Patients in this group will continue with DAPT (aspirin and a P2Y12 inhibitor) for the full 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPT de-escalation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI | NACCE is a composite of major adverse cardiovascular events (MACEs) and cerebrovascular events, and any significant bleeding event (classified according to BARC 2-5). Cumulative risk of NACCE will be compared between the 1-month DAPT and 12-month DAPT groups. | 12 months of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month Target Vessel Failure (TVF) Rate | TVF is defined as a composite of target vessel myocardial infarction (TVMI), target vessel revascularization (TVR), or cardiovascular death related to the target vessel. Cumulative incidence of TVF will be compared between each treatment group. | 12 months of enrollment |
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Inclusion Criteria:
Patients aged 18 years or older.
Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
Patients with the following clinical indications for PCI:
Patients who agree to participate and provide informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vu H Vu, MD, PhD | Contact | +84908431304 | vu.vh@umc.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of Ho Chi Minh City | Ho Chi Minh City | 70000 | Vietnam |
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| 12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) |
MACCE includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and clinically-driven revascularization or definite stent thrombosis. Cumulative risk of MACCE will be compared between the 1-month DAPT and 12-month DAPT groups. |
| 12 months of enrollment |
| Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale | To compare the rate of significant bleeding, classified according to the Bleeding Academic Research Consortium (BARC) types 2 to 5, between the two groups. | 12 months of enrollment |
| Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data) | This outcome measure will include a detailed analysis of the clinical characteristics of patients undergoing PCI. The data will include demographics (age, gender), cardiovascular risk factors (diabetes, hypertension, smoking status), previous cardiovascular events, and other relevant clinical history such as comorbidities. Data will be summarized as means (for continuous variables like age) or percentages (for categorical variables like gender and risk factors). This measure aims to provide a baseline comparison between the two study groups (1-month DAPT vs. 12-month DAPT) | 12 months of enrollment |