Status:
NOT_YET_RECRUITING
Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Sino Medical Sciences Technology Inc.
Conditions:
High Bleeding Risk Patients
Cardiology
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT07140133
Start Date
September 1 2025
End Date
September 1 2027
Last Update
August 24 2025
Active Locations (1)
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1
Chu Grenoble Alpes
Grenoble, Isère, France, 38700