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NCT06648720 | NOT YET RECRUITING | Coronary Arterial Disease (CAD)

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

University Medical Center Ho Chi Minh City (UMC)

Information provided by (Responsible Party):

Vu Hoang Vu

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.

Condition or disease

Coronary Arterial Disease (CAD)

Percutaneous Coronary Intervention (PCI)

Intravascular Ultrasound

Dual Antiplatelet Therapy

Intervention/treatment

DAPT de-escalation

Phase

NA

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
Estimated Enrollment : 3566 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial
Actual Study Start Date : 2025-03-01
Estimated Primary Completion Date : 2028-03-01
Estimated Study Completion Date : 2029-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients

Location Details

NCT06648720

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How to Participate

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Locations

Not yet recruiting

Vietnam,

University Medical Center of Ho Chi Minh City

Ho Chi Minh, Vietnam, 70000