High Bleeding Risk PatientsDIOHRNCT07140133
Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
An observational study of High Bleeding Risk Patients and Cardiology, run by University Hospital, Grenoble at 1 site in France.
Trial 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 well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Bleeding Risk Patients, Cardiology, Stent Implantation
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu Grenoble Alpes
Grenoble, Isère, 38700
Clémence Charlon, 0476766823, ccharlon@chu-grenoble.fr
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 335 days
Secondary outcomes (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.
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
Measured: At 335 days and one year
Evaluate the one-year frequency of death from any cause
All-cause death rate
Measured: At 335 days and one year
Evaluate the one-year frequency of cardiovascular deaths
Cardiovascular death rate
Measured: At 335 days and one year
Evaluate the one-year incidence of myocardial infarction
Myocardial infarction rate
Measured: At 335 days and one year
Evaluate the one-year incidence of ischemic stroke
Ischemic stroke rate
Measured: At 335 days and one year
Evaluate the one-year frequency of ischemia-driven revascularizations
ischemia-driven revascularizations rate
Measured: One year
Evaluate the one-year incidence of defined stent thrombosis
defined stent thrombosis rate
Measured: One year
Assess the one-year frequency of minor and major bleeding according to Bleeding Academic Research Consortium (BARC)
minor and major bleeding according to Bleeding Academic Research Consortium (BARC) rate
Measured: One year
Evaluate the frequency of other cardiovascular adverse events
other cardiovascular adverse events rate
Measured: at 335 days and One year
Evaluate the rate of serious adverse events related to the device and/or investigation procedure.
Rate of serious adverse events related to the device and/or investigation procedure
Measured: At 335 and One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Bleeding Risk PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Sino Medical Sciences Technology Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140133
- Sponsor's protocol ID
- 38RC25.0204
- Acronym
- DIOHR
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
- ClinicalTrials.gov ID
- NCT07140133
- Acronym / sponsor ID
- DIOHR / 38RC25.0204
- Conditions
- High Bleeding Risk Patients, Cardiology, Stent Implantation, DAPT(Dual Antiplatelet Therapy)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Sino Medical Sciences Technology Inc.
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Bleeding Risk Patients and Cardiology, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.