Acute Coronary SyndromeNCT02038309
Persistent Platelet Reactivity in Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Hopital Lariboisière at 1 site in France.
Trial summary
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2015
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Acute coronary syndrome
Who may be able to join
- acute coronary syndrome with elevation in troponin
Who cannot join
- anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.
Read the detailed description
Blood samples are performed on day 2 and 4 and collected with usual blood samples and analyzed by the laboratory. Maximal aggregation intensity and velocity are measured by light transmission aggregometry induced by arachidonic acid (AA) or adenosine diphosphate (ADP). Platelet function analyzer will be also used. No changes in treatment in response to the results is planned.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, persistent platelet reactivity
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum aggregation intensity
Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the acute phase (day2-day 5)
Measured: day 2
Secondary outcomes (2)
Maximum aggregation intensity
Light transmission aggregometry following exposition to adenosine diphosphate during the acute phase (day2-day 5) and during the chronic phase (day 30-day 60)
Measured: Day 2
Maximum aggregation intensity
Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the chronic phase (day 30-day 60)
Measured: Chronic phase (day 30 to day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2015
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
- 106 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jean-Guillaume DILLINGER, Hopital Lariboisière
- Investigators
- Patrick Henry, MD-PhD, Study director, Department of Cardiology - Lariboisiere Hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038309
- Sponsor's protocol ID
- PPRACS
- Status last verified
- Jan 2014
- First submitted
- 12 Jan 2014
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Platelet Reactivity in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02038309
- Acronym / sponsor ID
- PPRACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, persistent platelet reactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jan 2014 (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.
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.
Detailed description
Blood samples are performed on day 2 and 4 and collected with usual blood samples and analyzed by the laboratory. Maximal aggregation intensity and velocity are measured by light transmission aggregometry induced by arachidonic acid (AA) or adenosine diphosphate (ADP). Platelet function analyzer will be also used. No changes in treatment in response to the results is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome
Key inclusion criteria (1 listed)
- acute coronary syndrome with elevation in troponin
Key exclusion criteria (1 listed)
- anticoagulant treatment
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
maximum aggregation intensity
Time frame: day 2
Light transmission aggregometry following exposition to arachidonic acid 0.5mg/ml during the acute phase (day2-day 5)
2 secondary outcomes
Maximum aggregation intensity
Time frame: Day 2
Maximum aggregation intensity
Time frame: Chronic phase (day 30 to day 60)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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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.
Patrick Henry, MD-PhD study director
Department of Cardiology - Lariboisiere Hospital - APHP
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, run by Hopital Lariboisière 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 1 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: finished, as of the sponsor's last update on 25 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum aggregation intensity (time frame: day 2). 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 25 Jul 2024.