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Not yet recruiting NCT07140133

Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: High Bleeding Risk Patients, Cardiology, Stent Implantation, DAPT(Dual Antiplatelet Therapy). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • 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]
  • Evaluate the one-year frequency of death from any cause [Time frame: At 335 days and one year]
  • Evaluate the one-year frequency of cardiovascular deaths [Time frame: At 335 days and one year]
  • Evaluate the one-year incidence of myocardial infarction [Time frame: At 335 days and one year]
  • Evaluate the one-year incidence of ischemic stroke [Time frame: At 335 days and one year]
  • Evaluate the one-year frequency of ischemia-driven revascularizations [Time frame: One year]
  • Evaluate the one-year incidence of defined stent thrombosis [Time frame: One year]
  • Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC) [Time frame: One year]
  • Evaluate the frequency of other cardiovascular adverse events [Time frame: at 335 days and One year]
  • Evaluate the rate of serious adverse events related to the device and/or investigation procedure. [Time frame: At 335 and One year]

Eligibility criteria

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chu Grenoble Alpes — Grenoble

Identifiers

NCT: NCT07140133 · 38RC25.0204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗