Cerebrovascular DisordersNCT03679858
Platelet Antisedimentation Rate and Multiplate Exams in Patients on Antiplatelet Therapy and Controls
An observational study of Cerebrovascular Disorders and Platelet Refractoriness, run by University of Pecs at 1 site in Hungary.
Trial summary
To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disorders, Platelet Refractoriness, Platelet Aggregation, Spontaneous
- What is being tested?
- Platelet function test
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2018to 1 Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with cerebrovascular disorders on antiplatelet therapy as a secundary prevention.
Who may be able to join
- Written informed consent
Who cannot join
- Declined informed consent
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs
Pécs, Baranya, 7624
Erzsebet Ezer, MD, +36302882415, ezererzsebet@yahoo.com
Lajos Bogar, MD, DSc, +36302889503, bogar.lajos@pte.hu
About this study
Official title: Platelet Antisedimentation Rate and Multiplate ex Vivo Examinations in Cerebrovascular Patients Treated With Antiplatelet Therapy and Healthy Controls
To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.
- Being tested
- Platelet function test
- Medical subject headings
- Cerebrovascular Disorders, Platelet Aggregation, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet function testOther
Ex vivo platelet aggregation analysis by Multiplate aggregometer
| Study group | Role | What they receive |
|---|---|---|
| Platelet function test in patients | Platelet function test in patients on antiplatelet therapy Receives: Other: Platelet function test | |
| Platelet function test in healthy | Platelet function test in healthy subjects Receives: Other: Platelet function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cerebrovascular event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tihamér Molnár, University of Pecs
- Investigators
- Tihamer Molnar, MD, PhD, Principal investigator, University of Pécs Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679858
- Sponsor's protocol ID
- PTE6735
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant's aggregometry data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Antisedimentation Rate and Multiplate ex Vivo Examinations in Cerebrovascular Patients Treated With Antiplatelet Therapy and Healthy Controls
- ClinicalTrials.gov ID
- NCT03679858
- Acronym / sponsor ID
- PTE6735
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 20 Sep 2018 (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.
To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet function test in patients | – | Other: Platelet function testPlatelet function test in patients on antiplatelet therapy |
| Platelet function test in healthy | – | Other: Platelet function testPlatelet function test in healthy subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebrovascular disorders on antiplatelet therapy as a secundary prevention.
Key inclusion criteria (1 listed)
- Written informed consent
Key exclusion criteria (1 listed)
- Declined informed consent
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 |
|---|---|---|
| Platelet function testEx vivo platelet aggregation analysis by Multiplate aggregometer | Other | Platelet function test in healthy, Platelet function test in patients |
Primary outcome
Major cerebrovascular event
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- description about Multiple Electrode AggregometryLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant's aggregometry data will be shared with other researchers.
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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.
Tihamer Molnar, MD, PhD principal investigator
University of Pécs Medical School
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 Cerebrovascular Disorders and Platelet Refractoriness, run by University of Pecs at 1 site in Hungary.
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: status not confirmed, as of the sponsor's last update on 24 Sep 2018. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tihamer Molnar, MD, PhD (+36302275814, tihamermolnar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cerebrovascular event (time frame: 1 year). 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 Sep 2018.