OCT-based DAPT Cessation in HBR Patients

NCT07238764 | Completed

• 1 other identifier: OCT-DAPT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether patients with diabetes mellitus (DM) and a high risk of bleeding can safely stop dual antiplatelet therapy (DAPT) earlier than usual after receiving a special type of stent called a polymer-free amphilimus-eluting stent. DAPT, which combines aspirin and a P2Y12 inhibitor, is typically prescribed for six months after stent placement to prevent blood clots. However, in patients at high risk of bleeding, stopping DAPT early may be beneficial if the artery has healed properly. The study uses optical coherence tomography (OCT), a high-resolution imaging tool, to assess how well the artery has healed after stent placement. If OCT shows that at least 80% of the stent is covered by new tissue after one month, patients in the short DAPT group stop taking DAPT and switch to a single antiplatelet drug for up to six months. In the standard DAPT group, patients continue taking both drugs for the full six months. The goal of the study is to determine whether early DAPT discontinuation guided by OCT is as safe as the standard six-month treatment. The study focuses on two main outcomes: (1) how well the artery heals, measured by the percentage of stent coverage seen on OCT, and (2) the occurrence of major complications such as heart attack, stroke, or severe bleeding over 12 months. This research is important because patients with diabetes often face delayed healing and a higher risk of blood clots, making it challenging to balance the risks of clotting and bleeding. The polymer-free amphilimus-eluting stent used in this study is designed to promote faster healing and reduce inflammation, potentially allowing for safer early DAPT discontinuation. Additionally, OCT provides precise information about arterial healing, helping doctors make personalized decisions about when to stop DAPT. By comparing the safety and effectiveness of short DAPT versus standard DAPT, this study aims to improve treatment strategies for high-risk patients, reducing the risk of both bleeding and clot-related complications. If successful, this approach could lead to more tailored and safer antiplatelet therapy for patients with diabetes and high bleeding risk.

Conditions

High Bleeding Risk Patients; DAPT(Dual Antiplatelet Therapy); Coronary Artery Disease; Diabetes Mellitus

Keywords

Optical coherence tomography; dual antiplatelet therapy; amphilimus-eluting stent; high-bleeding risk; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• The percentage of covered stent struts assessed by OCT at 1 month. The primary safety endpoint, defined as net adverse clinical events (NACE), included the incidence of cardiac death, non-fatal myocardial infarction (MI), stroke, or major bleeding.

  1 month

Secondary Outcomes (1)

• Incidence of stent thrombosis and other MACE. Bleeding complications were assessed according to the BARC criteria.

  The follow-up period was 12 months

Study Arms (2)

Standard DAPT (6 months)

NO INTERVENTION

Standard DAPT therapy according to clinical guidelines

Short DAPT (1 month)

EXPERIMENTAL

DAPT cessation at 1 month post-PCI based on optical coherence tomography results

Procedure: Optical Coherence Tomography-based early DAPT discontinuation

Interventions

Optical Coherence Tomography-based early DAPT discontinuation PROCEDURE

Within one month after the index PCI, participants in the short DAPT group underwent coronary angiography with OCT assessment of the implanted stents. If prespecified OCT criteria for adequate arterial healing were met (i.e., ≥80% neointimal strut coverage), DAPT was discontinued immediately, and SAPT with P2Y12 inhibitors was prescribed for up to six months.

Short DAPT (1 month)

Eligibility Criteria

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

You may qualify if:

• Diabetes mellitus (type 1 or type 2)
• Coronary artery disease (CAD) suitable for drug-eluting stent (DES) implantation
• High-bleeding risk as defined by the Academic Research Consortium (ARC) or a Precise-DAPT score ≥ 25

You may not qualify if:

• Acute coronary syndrome (ACS)
• Active bleeding at the time of randomization
• Known renal impairment (glomerular filtration rate \[GFR\] ≤ 20 ml/min)
• Reduced left ventricular ejection fraction (LVEF ≤ 30%)

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: lead

Study Sites (1)

Almazov National Medical Research Center of the Ministry of Health of the Russian Federation

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandra O. Conradi, PhD

  Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy General Director for Research of the Almazov National Medical Research Center of the Ministry of Health of the Russian Federation

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: November 20, 2025
• Study Start: June 12, 2022
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)