Acquired Platelet DisorderNCT01839968
Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel
An observational study of Acquired Platelet Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Platelet Disorder
- What is being tested?
- Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Jan 2014
- 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: Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.
Who may be able to join
- Acute coronary syndrome
- Prasugrel loading dose 6-24h before inclusion
Who cannot join
- Clopidogrel loading dose
- GPIIbIIIa use within 10 days before inclusion
- Known congenital thrombopathy and/or congenital coagulation defect
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva
Geneva, Canton of Geneva, 1205
About this study
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.
- Conditions
- Acquired Platelet Disorder
- Being tested
- Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasmaOther
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Acute coronary syndrome patients with a recent loading dose of prasugrel (6-24h) Receives: Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition
Measured: within the first 6-24 hours after antiplatelet drug loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Platelet DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fanny Bonhomme, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839968
- Sponsor's protocol ID
- 11-117
- Status last verified
- Aug 2014
- First submitted
- 22 Apr 2013
- Last updated
- 19 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel
- ClinicalTrials.gov ID
- NCT01839968
- Acronym / sponsor ID
- 11-117
- Conditions
- Acquired Platelet Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Apr 2013 (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.
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | – | Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasmaAcute coronary syndrome patients with a recent loading dose of prasugrel (6-24h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome who received a loading dose of prasugrel within 6 and 24h.
Key inclusion criteria (2 listed)
- Acute coronary syndrome
- Prasugrel loading dose 6-24h before inclusion
Key exclusion criteria (3 listed)
- Clopidogrel loading dose
- GPIIbIIIa use within 10 days before inclusion
- Known congenital thrombopathy and/or congenital coagulation defect
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 |
|---|---|---|
| Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma | Other | Study patients |
Primary outcome
Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition
Time frame: within the first 6-24 hours after antiplatelet drug loading dose
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 19 Aug 2014.
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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.
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 Acquired Platelet Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 19 Aug 2014. 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 Switzerland. 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?
Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition (time frame: within the first 6-24 hours after antiplatelet drug loading dose). 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 19 Aug 2014.