Menu
Not yet recruiting NCT06648720

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

No phase Interventional Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI) Intravascular Ultrasound Dual Antiplatelet Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DAPT de-escalation.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Intravascular Ultrasound, Dual Antiplatelet Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI [Time frame: 12 months of enrollment]
Secondary outcome measures (4)
  • 12-month Target Vessel Failure (TVF) Rate [Time frame: 12 months of enrollment]
  • 12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Time frame: 12 months of enrollment]
  • Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale [Time frame: 12 months of enrollment]
  • Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data) [Time frame: 12 months of enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Vietnam · 1 center
  • University Medical Center of Ho Chi Minh City — Ho Chi Minh City

Identifiers

NCT: NCT06648720 · SHORTDAPT IVUS Trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗