Acute Coronary SyndromeNCT06177587
Multimarker Evaluation of Platelet Activity and Agregation in ACS
An observational study of Acute Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI) are at a higher risk of ischemic complications, even while receiving proper dual antiplatelet therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Assesment of biomarkers in acute coronary syndromes
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2017to 8 Dec 2023
- 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: Adult population diagnosed with ACS on admission and treated primarily with PCI.
Who may be able to join
- Ability to provide written informed consent in a time window 1-24 hours after successful PCI;
- Male or female, age ≥ 18 years at screening;
- ACS at the time of the index hospitalization;
- ACS patients undergoing PCI (New-Generation DES)
- Use of a loading dose of P2Y12 inhibitor administered after diagnosis of ACS or after PCI;
Who cannot join
- Unstable clinical status (hemodynamic or electrical instability);
- Planned surgery requiring DAPT discontinuation during the study;
- Coronary Revascularization (Surgical or Intervention) Program within 90 days
- Prior stroke, transient ischemic attack or intracranial bleeding;
- Active bleeding;
- Severe anemia (hemoglobin < 8g/dL);
Show all 16Show fewer
- Platelet count ≤70x10^3/ml;
- Hematocrit of < 30% or > 52%
- Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);
- Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);
- Known hypersensitivity or contraindication to ASA, clopidogrel, ticagrelor or prasugrel;
- Under judicial protection, tutorship or curatorship;
- Pregnancy;
- Unable to understand and follow study-related instructions;
- Enrollment in another investigational device or drug study.
- Unable to provide an informed consent.
Trial locations and contacts
1 site in 1 country.
Poland1 site
I Department and Clinic of Cardiology, Medical University of Warsaw
Warsaw, 00-001
About this study
Official title: Multimarker Evaluation of Platelet Activity and Agregation in Patients Presenting With Acute Coronary Syndrome: Prospective Observational Study
Patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI) are at a higher risk of ischemic complications, even while receiving proper dual antiplatelet therapy. For this reason, identifying high-risk patients and personalizing treatment according to their profile could be a solution towards improving the efficacy and safety of the antiplatelet treatment.
This is a prospective single centre study analyzing correlations and clinical outcomes of patients in relation to biomarkers in acute coronary syndrome. The blood samples were collected from patients admitted to the hospital with a diagnosis of ACS and treated with dual antiplatelet therapy.
The blood samples were collected from each patient within the first 24 hours after the admission for acute coronary syndrome (ACS) and after 72 hours of hospitalization.
Read the detailed description
In this prospective, single-center, observational study, adult patients meeting the inclusion/exclusion criteria were included. Subjects enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology; Medical University of Warsaw (Poland) were cathegorized into three arms: 1) treated with aspirin and clopidogrel, 2) treated with aspirin and ticagrelor; 3) treated with aspirin and prasugrel. In all three groups subjects first obtained the loading dose of the drug and thereafter they received a fixed daily dose.
Blood samples were collected form each patient at two time-points: during the first 24 hours from hospital admission and after 72 hours following hospital admission. The parameters measured included selected platelet-derived microRNAs prticles, immature platelet fraction (IPF) and platelet microvesicles' comncentration. Platelet reactivity was established using Multiplate® Analyzer (Roche).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Assesment of biomarkers in acute coronary syndromes
- Keywords
- Acute Coronary Syndrome, Biomarkers, IPF, Immature Platelet Fraction, ADP test, Antiplatelet therapy
- 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.
Assesment of biomarkers in acute coronary syndromesOther
Collection of 20ml of blood from peripheral vein.
| Study group | Role | What they receive |
|---|---|---|
| Assesment of platelet biomarkers in acute coronary syndromes - low level of parameters | Blood is collected within the first 24 hours from hospital admission and after 72 hours following hospital admission. The level of selected biomarkers is measured. Receives: Other: Assesment of biomarkers in acute coronary syndromes | |
| Assesment of platelet biomarkers in acute coronary syndromes - high level of parameters | Blood is collected within the first 24 hours from hospital admission and after 72 hours following hospital admission. The level of selected biomarkers is measured. Receives: Other: Assesment of biomarkers in acute coronary syndromes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the selected biomarkers in patients with acute coronary syndrome in the first 24 hours from hospital admission and major adverse cardiovascular events (MACE)
MACE defined as the composite endpoint of all-cause death, myocardial infarction, stroke, unplanned revascularization.
Measured: 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2017
- Primary completion1 Dec 2022
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177587
- Sponsor's protocol ID
- MULTIMARKER-ACS
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gumiezna K, Bednarek A, Sygitowicz G, Maciejak-Jastrzebska A, Barus P, Hunia J, Klimczak-Tomaniak D, Kochman J, Grabowski M, Tomaniak M. Platelet microRNAs as Potential Novel Biomarkers for Antiplatelet Therapy with P2Y12 Inhibitors and Their Association with Platelet Function. J Clin Med. 2023 Dec 22;13(1):63. doi: 10.3390/jcm13010063.
PubMed 38202070Gumiezna K, Barus P, Sygitowicz G, Wisniewska A, Bednarek A, Zablocki J, Piasecki A, Klimczak-Tomaniak D, Kochman J, Grabowski M, Tomaniak M. Prognostic Implications of Immature Platelet Fraction at 5-Year Follow-up Among ACS Patients Treated With Dual Antiplatelet Therapy. J Cardiovasc Pharmacol Ther. 2024 Jan-Dec;29:10742484231202864. doi: 10.1177/10742484231202864.
PubMed 38196286Gumiezna K, Bednarek A, Sygitowicz G, Barus P, Wisniewska A, Klimczak-Tomaniak D, Kochman J, Opolski G, Grabowski M, Tomaniak M. Immature platelet fraction and immature platelet count as novel biomarkers of elevated platelet reactivity in NSTE-ACS patients receiving dual antiplatelet therapy. Adv Clin Exp Med. 2023 Dec;32(12):1465-1470. doi: 10.17219/acem/177406.
PubMed 38126718
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimarker Evaluation of Platelet Activity and Agregation in Patients Presenting With Acute Coronary Syndrome: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06177587
- Acronym / sponsor ID
- MULTIMARKER-ACS
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Biomarkers, IPF, Immature Platelet Fraction, ADP test, Antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 20 Dec 2023 (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.
Patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI) are at a higher risk of ischemic complications, even while receiving proper dual antiplatelet therapy. For this reason, identifying high-risk patients and personalizing treatment according to their profile could be a solution towards improving the efficacy and safety of the antiplatelet treatment.
This is a prospective single centre study analyzing correlations and clinical outcomes of patients in relation to biomarkers in acute coronary syndrome. The blood samples were collected from patients admitted to the hospital with a diagnosis of ACS and treated with dual antiplatelet therapy.
The blood samples were collected from each patient within the first 24 hours after the admission for acute coronary syndrome (ACS) and after 72 hours of hospitalization.
Detailed description
In this prospective, single-center, observational study, adult patients meeting the inclusion/exclusion criteria were included. Subjects enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology; Medical University of Warsaw (Poland) were cathegorized into three arms: 1) treated with aspirin and clopidogrel, 2) treated with aspirin and ticagrelor; 3) treated with aspirin and prasugrel. In all three groups subjects first obtained the loading dose of the drug and thereafter they received a fixed daily dose.
Blood samples were collected form each patient at two time-points: during the first 24 hours from hospital admission and after 72 hours following hospital admission. The parameters measured included selected platelet-derived microRNAs prticles, immature platelet fraction (IPF) and platelet microvesicles' comncentration. Platelet reactivity was established using Multiplate® Analyzer (Roche).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assesment of platelet biomarkers in acute coronary syndromes - low level of parameters | – | Other: Assesment of biomarkers in acute coronary syndromesBlood is collected within the first 24 hours from hospital admission and after 72 hours following hospital admission. The level of selected biomarkers is measured. |
| Assesment of platelet biomarkers in acute coronary syndromes - high level of parameters | – | Other: Assesment of biomarkers in acute coronary syndromesBlood is collected within the first 24 hours from hospital admission and after 72 hours following hospital admission. The level of selected biomarkers is measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population diagnosed with ACS on admission and treated primarily with PCI.
Key inclusion criteria (5 listed)
- Ability to provide written informed consent in a time window 1-24 hours after successful PCI;
- Male or female, age ≥ 18 years at screening;
- ACS at the time of the index hospitalization;
- ACS patients undergoing PCI (New-Generation DES)
- Use of a loading dose of P2Y12 inhibitor administered after diagnosis of ACS or after PCI;
Key exclusion criteria (16 listed)
- Unstable clinical status (hemodynamic or electrical instability);
- Planned surgery requiring DAPT discontinuation during the study;
- Coronary Revascularization (Surgical or Intervention) Program within 90 days
- Prior stroke, transient ischemic attack or intracranial bleeding;
- Active bleeding;
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 |
|---|---|---|
| Assesment of biomarkers in acute coronary syndromesCollection of 20ml of blood from peripheral vein. | Other | Assesment of platelet biomarkers in acute coronary syndromes - high level of parameters, Assesment of platelet biomarkers in acute coronary syndromes - low level of parameters |
Primary outcome
Correlation between the selected biomarkers in patients with acute coronary syndrome in the first 24 hours from hospital admission and major adverse cardiovascular events (MACE)
Time frame: 50 months
MACE defined as the composite endpoint of all-cause death, myocardial infarction, stroke, unplanned revascularization.
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 20 Dec 2023.
- Derived from this study: PubMed 38202070Gumiezna K, Bednarek A, Sygitowicz G, Maciejak-Jastrzebska A, Barus P, Hunia J, Klimczak-Tomaniak D, Kochman J, Grabowski M, Tomaniak M. Platelet microRNAs as Potential Novel Biomarkers for Antiplatelet Therapy with P2Y12 Inhibitors and Their Association with Platelet Function. J Clin Med. 2023 Dec 22;13(1):63. doi: 10.3390/jcm13010063.
- Derived from this study: PubMed 38196286Gumiezna K, Barus P, Sygitowicz G, Wisniewska A, Bednarek A, Zablocki J, Piasecki A, Klimczak-Tomaniak D, Kochman J, Grabowski M, Tomaniak M. Prognostic Implications of Immature Platelet Fraction at 5-Year Follow-up Among ACS Patients Treated With Dual Antiplatelet Therapy. J Cardiovasc Pharmacol Ther. 2024 Jan-Dec;29:10742484231202864. doi: 10.1177/10742484231202864.
- Derived from this study: PubMed 38126718Gumiezna K, Bednarek A, Sygitowicz G, Barus P, Wisniewska A, Klimczak-Tomaniak D, Kochman J, Opolski G, Grabowski M, Tomaniak M. Immature platelet fraction and immature platelet count as novel biomarkers of elevated platelet reactivity in NSTE-ACS patients receiving dual antiplatelet therapy. Adv Clin Exp Med. 2023 Dec;32(12):1465-1470. doi: 10.17219/acem/177406.
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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 Acute Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
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 5 inclusion and 16 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 20 Dec 2023. 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 Poland. 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?
Correlation between the selected biomarkers in patients with acute coronary syndrome in the first 24 hours from hospital admission and major adverse cardiovascular events (MACE) (time frame: 50 months). 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 NCT06177587, which also lists 3 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 20 Dec 2023.