Acute Coronary SyndromeONASSISTNCT02762162
Registry of Coronary Artery Ill Patients With Platelet Test Results
An observational study of Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Action, France at 1 site in France.
Trial summary
ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention, Myocardial Infarction
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Jan 2037
- How long will I take part?
- 10 Years
- 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: coronary ill patients who have had a functionnal test mesuring antiplatelet effect and / or a genetic profile of response to antiplatelet drugs.
Who may be able to join
- coronary disease
- antiplatelets testing performed as part of usual care and / or gentic profile of antiplatelet response done
Who cannot join
- patient refusing to be part of the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Online Assistance for Stent Thrombosis
ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.
Read the detailed description
The Onassist Project is an assistance for cardiologists that establishes an individual risk of stent thrombosis for each patient based on:
- a functional approach (evaluation of the antiplatelet effect of the antiplatelet regimen by multiple tests) and
- a pharmacogenomic approach (genetic profile of response to antiplatelet agents) It provides advices for specific therapeutics after identification of adverse drug interactions, treatment compliance issues and true genetic, functional or mixed resistance.
This individualized strategy allow to adjust the choice of the drugs and their optimal dosage considering the best benefit - risk ratio.
Follow up are regularly made to identify markers of MACE (major adverse cardiac event) or bleeding.
- Keywords
- antiplatelet, stent thrombosis
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
all bleeding according to the BARC (Bleeding Academic Research Consortium) definitions are registered during the follow up
Measured: 10 years
Myocardial Infarction
Measured: 10 years
Death
Measured: 10 years
Stroke
Measured: 10 years
Urgent Revascularization
Measured: 10 years
Resuscitated Cardiac Arrest
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2007
- Primary completionJan 2027 (estimated)
- Study completionJan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Action, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762162
- Sponsor's protocol ID
- ONASSIST
- Acronym
- ONASSIST
- Status last verified
- Jan 2019
- First submitted
- 3 May 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Assistance for Stent Thrombosis
- ClinicalTrials.gov ID
- NCT02762162
- Acronym / sponsor ID
- ONASSIST / ONASSIST
- Keywords
- antiplatelet, stent thrombosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Action, FranceUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2037 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.
Detailed description
The Onassist Project is an assistance for cardiologists that establishes an individual risk of stent thrombosis for each patient based on:
- a functional approach (evaluation of the antiplatelet effect of the antiplatelet regimen by multiple tests) and
- a pharmacogenomic approach (genetic profile of response to antiplatelet agents) It provides advices for specific therapeutics after identification of adverse drug interactions, treatment compliance issues and true genetic, functional or mixed resistance.
This individualized strategy allow to adjust the choice of the drugs and their optimal dosage considering the best benefit - risk ratio.
Follow up are regularly made to identify markers of MACE (major adverse cardiac event) or bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- coronary ill patients who have had a functionnal test mesuring antiplatelet effect and / or a genetic profile of response to antiplatelet drugs.
Key inclusion criteria (2 listed)
- coronary disease
- antiplatelets testing performed as part of usual care and / or gentic profile of antiplatelet response done
Key exclusion criteria (1 listed)
- patient refusing to be part of the registry
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
Bleeding
Time frame: 10 years
all bleeding according to the BARC (Bleeding Academic Research Consortium) definitions are registered during the follow up
Myocardial Infarction
Time frame: 10 years
Death
Time frame: 10 years
Stroke
Time frame: 10 years
Urgent Revascularization
Time frame: 10 years
Resuscitated Cardiac Arrest
Time frame: 10 years
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 30 Jan 2019.
- Individual participant dataSharing planned: Yes
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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 Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Action, France 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Jan 2019. 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?
Contact Jean Philippe COLLET, MD, PhD (+33142162962, jean-philippe.collet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: 10 years). The study lists 6 primary outcomes in all. 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 30 Jan 2019.