Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial population
Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)).
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)
Time frame
At 335 daysSecondary 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.
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
Time frame
At 335 days and one year2
Evaluate the one-year frequency of death from any cause
All-cause death rate
Time frame
At 335 days and one year3
Evaluate the one-year frequency of cardiovascular deaths
Cardiovascular death rate
Time frame
At 335 days and one year4
Evaluate the one-year incidence of myocardial infarction
Myocardial infarction rate
Time frame
At 335 days and one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Sino Medical Sciences Technology Inc.
Collaborator
Source ClinicalTrials.gov
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