Platelet Aggregation OnhibitorsLAPCORNCT02264912
The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
An observational study of Platelet Aggregation Onhibitors, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Aggregation Onhibitors
- What is being tested?
- antiplatelet drugs - P2Y12 antagonists
- How many people
- 2,016 participants
- Where
- 1 siteCzechia
- Study dates
- Jul 2008to Jul 2018
- How long will I take part?
- 12 Months
- 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 were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation.
Who may be able to join
- Patients after stent PCI treated with P2Y12 antagonist
- Written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation. Efficacy of P2Y12 receptor antagonists has been measured by quantitative flow cytometric analysis of vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months and one year follow up has been investigated.
- Conditions
- Platelet Aggregation Onhibitors
- Being tested
- antiplatelet drugs - P2Y12 antagonists
- Keywords
- antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiplatelet drugs - P2Y12 antagonistsDrug
Also called clopidogrel, prasugrel, ticagrelor
| Study group | Role | What they receive |
|---|---|---|
| stent-PCI patients | Consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis. Receives: Drug: antiplatelet drugs - P2Y12 antagonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications
Measured: During the 12 months after implantation of an intracoronary stent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJul 2008
- Primary completionAug 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation OnhibitorsStudies 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
- 2,016 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zuzana Motovska, Faculty Hospital Kralovske Vinohrady
- Investigators
- Zuzana Motovska, MD.PhD., Principal investigator, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264912
- Sponsor's protocol ID
- 05-2008
- Acronym
- LAPCOR
- Status last verified
- Jul 2020
- First submitted
- 9 Oct 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.
PubMed 22154314Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.
PubMed 24728851Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.
PubMed 26797336Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a "Real World" registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.
PubMed 25917561
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laboratory AntiPlatelet Efficacy and Clinical Outcome Registry
- ClinicalTrials.gov ID
- NCT02264912
- Acronym / sponsor ID
- LAPCOR / 05-2008
- Conditions
- Platelet Aggregation Onhibitors
- Keywords
- antiplatelets, percutanous coronary intervention, acute coronary syndromes, laboratory efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- Jul 2008
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Oct 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.
The ongoing LAPCOR (Laboratory AntiPlatelet efficacy and Clinical Outcome Registry) registry was initiated in 2008 at a tertiary care cardiac center, and consecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis.Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation. Efficacy of P2Y12 receptor antagonists has been measured by quantitative flow cytometric analysis of vasodilator-stimulated phosphoprotein (VASP) phosphorylation according to the manufacturer protocol (Platelet VASP; Diagnostica Stago, Biocytex, Asnières, France) on a FACScan flow cytometer (Becton Dickinson). Occurrence of major adverse cardiac events at 30 days, 6-months and one year follow up has been investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stent-PCI patients | – | Drug: antiplatelet drugs - P2Y12 antagonistsConsecutive patients, who underwent intracoronary stent implantation, have been included regardless of whether percutaneous coronary intervention (PCI) was performed on urgent or elective basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were included in the registry after having signed an informed consent for participation. No exclusion criterion has been applied for the registry participation.
Key inclusion criteria (2 listed)
- Patients after stent PCI treated with P2Y12 antagonist
- Written informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| antiplatelet drugs - P2Y12 antagonistsAlso: clopidogrel, prasugrel, ticagrelor | Drug | stent-PCI patients |
Primary outcome
laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications
Time frame: During the 12 months after implantation of an intracoronary stent
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 22 Jul 2020.
- Results publication: PubMed 22154314Motovska Z, Odvodyova D, Fischerova M, Stepankova S, Maly M, Morawska P, Widimsky P. Renal function assessed using cystatin C and antiplatelet efficacy of clopidogrel assessed using the vasodilator-stimulated phosphoprotein index in patients having percutaneous coronary intervention. Am J Cardiol. 2012 Mar 1;109(5):620-3. doi: 10.1016/j.amjcard.2011.10.019. Epub 2011 Dec 10.
- Results publication: PubMed 24728851Motovska Z, Ondrakova M, Doktorova M, Widimsky P. Severe left ventricular systolic dysfunction is independently associated with high on-clopidogrel platelet reactivity. Am J Cardiovasc Drugs. 2014 Aug;14(4):313-8. doi: 10.1007/s40256-014-0074-3.
- Results publication: PubMed 26797336Ondrakova M, Knot J, Ulman J, Maly M, Motovska Z. Efficacy of P2Y12 receptor antagonists in patients with atrial fibrillation according to the CHA2DS2VASc score. Int J Cardiol. 2016 Mar 15;207:84-6. doi: 10.1016/j.ijcard.2016.01.039. Epub 2016 Jan 6. No abstract available.
- Results publication: PubMed 25917561Motovska Z, Ondrakova M, Bednar F, Knot J, Ulman J, Maly M. Selection of P2Y12 antagonist, treatment initiation, and predictors of high on-treatment platelet reactivity in a "Real World" registry. Thromb Res. 2015 Jun;135(6):1093-9. doi: 10.1016/j.thromres.2015.04.014. Epub 2015 Apr 16.
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.
Zuzana Motovska, MD.PhD. principal investigator
Faculty Hospital Kralovske Vinohrady
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 Platelet Aggregation Onhibitors, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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: finished, as of the sponsor's last update on 22 Jul 2020. 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 Czechia. 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?
laboratory efficacy of antiplatelet drugs measured as residual platelet reactivity, incidence of major adverse cardiovascular events and bleeding complications (time frame: During the 12 months after implantation of an intracoronary stent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264912, which also lists 4 linked publications.
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 22 Jul 2020.