Clinical trial NCT06648720: Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients
Official title: Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Intravascular Ultrasound
Dual Antiplatelet Therapy
Keywords: Shortening DAPT duration
Intravascular Ultrasound (IVUS)
Percutaenous Coronary Intervention (PCI)
Coronary Arterial Disease (CAD)
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2024-10-18
Enrollment: 3566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
timeFrame: 12 months of enrollment
Secondary outcomes:
measure: 12-month Target Vessel Failure (TVF) Rate
timeFrame: 12 months of enrollment
measure: 12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 12 months of enrollment
measure: Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale
timeFrame: 12 months of enrollment
measure: Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)
timeFrame: 12 months of enrollment
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University Medical Center of Ho Chi Minh City
Study officials:
References: