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OCT-based DAPT Cessation in HBR Patients

NCT07238764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

PROCEDURE

Optical Coherence Tomography-based early DAPT discontinuation

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Alexandra O. Conradi, PhD · Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-12
Primary Completion
2025-05-09
Completion
2025-05-09

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07238764 on ClinicalTrials.gov