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

NCT ID: NCT06648720

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3566 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2029-03-01

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.

Conditions

Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI); Intravascular Ultrasound; Dual Antiplatelet Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

DAPT de-escalation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role: collaborator

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role: lead

Responsible Party

Vu Hoang Vu

Head of Interventional Cardiology Department, PhD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center of Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Central Contacts

Vu H Vu, MD, PhD

Role: CONTACT

vu.vh@umc.edu.vn

+84908431304

Facility Contacts

Vu H Vu, MD, PhD

Role: primary

vu.vh@umc.edu.vn

+84‭908431304‬

Other Identifiers

SHORTDAPT IVUS Trial

Identifier Type: -

Identifier Source: org_study_id