OCT-based DAPT Cessation in HBR Patients

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 40
• From 12 Jun 2022 to the primary completion date, 9 May 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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