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

NCT06648720 | Not Yet Recruiting DMC

• 1 other identifier: SHORTDAPT IVUS Trial
• Study Type: interventional
• Target: 3,566
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 12-month Target Vessel Failure (TVF) Rate

  12 months of enrollment

• 12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  12 months of enrollment

• Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale

  12 months of enrollment

• Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)

  12 months of enrollment

Study Arms (2)

Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group)

EXPERIMENTAL

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

Group 2 (12-Month DAPT): Standard DAPT (Control Group)

NO INTERVENTION

Patients in this group will continue with DAPT (aspirin and a P2Y12 inhibitor) for the full 12 months.

Interventions

DAPT de-escalation 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 1 (1-Month DAPT): DAPT De-escalation (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center of Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Central Study Contacts

Vu H Vu, MD, PhD

CONTACT

+84908431304; vu.vh@umc.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional Cardiology Department, PhD MD

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 18, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)