Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients (SHORTDAPT)

Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dual Antiplatelet Therapy; Percutaneous Coronary Intervention (PCI); Intravascular Ultrasound; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Drug: DAPT de-escalation

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.

• Study Type: Interventional
• Enrollment (Estimated): 3566
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vu H Vu, MD, PhD; Phone Number: +84‭908431304‬; Email: vu.vh@umc.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam, 70000
    • University Medical Center of Ho Chi Minh City
    • Contact: Vu H Vu, MD, PhD; Phone Number: +84‭908431304‬; Email: vu.vh@umc.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  • Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency/severity of angina attacks.
  • Acute Myocardial Infarction (MI): With or without ST-elevation.
  • Chronic Coronary Syndrome: Requiring coronary revascularization.
• Patients who agree to participate and provide informed consent.

Exclusion Criteria:

• Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
• Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
• Coronary Artery Bypass Graft Surgery: History of CABG surgery.
• Planned Surgery: Patients who have surgeries planned within the next 12 months.
• Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
• Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.
• Thrombocytopenia: Platelet count less than 100,000/mm³.
• Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.
• Liver Disease: Patients with cirrhosis or significant liver dysfunction.
• Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
• Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group); 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.	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.
No Intervention: Group 2 (12-Month DAPT): Standard DAPT (Control Group); Patients in this group will continue with DAPT (aspirin and a P2Y12 inhibitor) for the full 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)
• Collaborators: University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Intravascular Ultrasound (IVUS); Shortening DAPT duration; Percutaenous Coronary Intervention (PCI); Coronary Arterial Disease (CAD)
• Other Study ID Numbers: SHORTDAPT IVUS Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No