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NCT Number: NCT07140133

Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome.

The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients.

Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.

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Key information

Conditions

High Bleeding Risk Patients Cardiology DAPT(Dual Antiplatelet Therapy) Stent Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥ 18 years
  • Male or female patient requiring a coronary angioplasty procedure according to European recommendations,
  • Patients undergoing revascularization with HT-supreme stents
  • Patient at high risk of bleeding according to ARC HBR definition (9).
  • Patient affiliated to or benefiting from a social security scheme
  • Patient who does not object to research

Exclusion criteria

  • Estimated lifespan <1 year,
  • Allergy and any other contraindication to aspirin and/or clopidogrel listed in the summary of product characteristics,
  • Allergy to iodinated contrast media
  • Adults under legal protection (guardianship, curatorship or safeguard of justice).
  • Persons deprived of their liberty by judicial or administrative decision,
  • Patient in a period of relative exclusion from another research protocol,

Treatment and study plan

Primary outcomes

  1. Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).

    Time frame: At 335 days

    Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo)

Secondary outcomes

  1. Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk.

    Time frame: At 335 days and one year

    the rate of occurrence of the primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) in patients with HBRand high ischemic risk

  2. Evaluate the one-year frequency of death from any cause

    Time frame: At 335 days and one year

    All-cause death rate

  3. Evaluate the one-year frequency of cardiovascular deaths

    Time frame: At 335 days and one year

    Cardiovascular death rate

  4. Evaluate the one-year incidence of myocardial infarction

    Time frame: At 335 days and one year

    Myocardial infarction rate

  5. Evaluate the one-year incidence of ischemic stroke

    Time frame: At 335 days and one year

    Ischemic stroke rate

  6. Evaluate the one-year frequency of ischemia-driven revascularizations

    Time frame: One year

    ischemia-driven revascularizations rate

  7. Evaluate the one-year incidence of defined stent thrombosis

    Time frame: One year

    defined stent thrombosis rate

  8. Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC)

    Time frame: One year

    minor and major bleeding according to Bleeding Academic Research Consortium (BARC) rate

  9. Evaluate the frequency of other cardiovascular adverse events

    Time frame: at 335 days and One year

    other cardiovascular adverse events rate

  10. Evaluate the rate of serious adverse events related to the device and/or investigation procedure.

    Time frame: At 335 and One year

    Rate of serious adverse events related to the device and/or investigation procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Sino Medical Sciences Technology Inc.

Registry information

Acronym: DIOHR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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