BleedingHEMOTRINCT03203980
Bleeding Events After Triple Antithrombotic Therapy Initiation.
An observational study of Bleeding, run by Central Hospital, Nancy, France.
Trial summary
The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- What is being tested?
- Triple antithrombotic therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2017to 15 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from the cardiology care unit of Nancy Central Hospital, hospitalised for coronary stenting and requiring oral anticoagulation (except VKA)
Who may be able to join
- patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation
Who cannot join
- history of bleeding
- patients already under triple antithrombotic therapy
- patients under vitamin K antagonists
About this study
Official title: Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life
The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard.
Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.
- Conditions
- Bleeding
- Being tested
- Triple antithrombotic therapy
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple antithrombotic therapyOther
patients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding events
Bleeding events with clinical significance
Measured: within 6 months since the initiation of triple antithrombotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start15 Jul 2017 (estimated)
- Primary completion15 Jan 2018 (estimated)
- Study completion15 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203980
- Sponsor's protocol ID
- 2017-A01733-50
- Acronym
- HEMOTRI
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life
- ClinicalTrials.gov ID
- NCT03203980
- Acronym / sponsor ID
- HEMOTRI / 2017-A01733-50
- Conditions
- Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 15 Jul 2018 (estimated)
- First posted
- 29 Jun 2017 (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.
The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard.
Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the cardiology care unit of Nancy Central Hospital, hospitalised for coronary stenting and requiring oral anticoagulation (except VKA)
Key inclusion criteria (1 listed)
- patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation
Key exclusion criteria (3 listed)
- history of bleeding
- patients already under triple antithrombotic therapy
- patients under vitamin K antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple antithrombotic therapypatients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA) | Other | – |
Primary outcome
Bleeding events
Time frame: within 6 months since the initiation of triple antithrombotic therapy
Bleeding events with clinical significance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding, run by Central Hospital, Nancy, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding events (time frame: within 6 months since the initiation of triple antithrombotic therapy). 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 11 Jul 2017.