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CompletedNCT06177587Updated Dec 20, 2023

Multimarker Evaluation of Platelet Activity and Agregation in ACS

An observational study in Acute Coronary Syndrome, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Medical University of Warsaw · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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. 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).

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Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Acute Coronary Syndrome
  • Biomarkers
  • IPF
  • Immature Platelet Fraction
  • ADP test
  • Antiplatelet therapy
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In context

Acute Coronary Syndrome

1,492 studies on the registry are indexed under Acute Coronary Syndrome; 270 are open to participants now.

This study's enrollment of 150 is below the median of 500 across 579 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult population diagnosed with ACS on admission and treated primarily with PCI.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to provide written informed consent in a time window 1-24 hours after successful PCI;
  2. Male or female, age ≥ 18 years at screening;
  3. ACS at the time of the index hospitalization;
  4. ACS patients undergoing PCI (New-Generation DES)
  5. Use of a loading dose of P2Y12 inhibitor administered after diagnosis of ACS or after PCI;

Exclusion criteria

Exclusion Criteria:

  1. Unstable clinical status (hemodynamic or electrical instability);
  2. Planned surgery requiring DAPT discontinuation during the study;
  3. Coronary Revascularization (Surgical or Intervention) Program within 90 days
  4. Prior stroke, transient ischemic attack or intracranial bleeding;
  5. Active bleeding;
  6. Severe anemia (hemoglobin \< 8g/dL);
  7. Platelet count ≤70x10\^3/ml;
  8. Hematocrit of \< 30% or > 52%
  9. Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);
  10. Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);
  11. Known hypersensitivity or contraindication to ASA, clopidogrel, ticagrelor or prasugrel;
  12. Under judicial protection, tutorship or curatorship;
  13. Pregnancy;
  14. Unable to understand and follow study-related instructions;
  15. Enrollment in another investigational device or drug study.
  16. Unable to provide an informed consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    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.

    Other: Assesment of biomarkers in acute coronary syndromes

Interventions

  • OtherAssesment of biomarkers in acute coronary syndromes

    Collection of 20ml of blood from peripheral vein.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 50 months

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Study locations

1 site
  • I Department and Clinic of Cardiology, Medical University of Warsaw
    Warsaw, 00-001, Poland
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References and documents

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 38202070 ↗
  • Gumiezna 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 38196286 ↗
  • Gumiezna 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06177587
Responsible party
Mariusz Tomaniak (Tomaniak Mariusz MD PhD, Medical University of Warsaw) — Principal investigator
First posted
Dec 20, 2023
Start date
Dec 1, 2017
Primary completion
Dec 1, 2022
Completion
Dec 8, 2023
Last update
Dec 20, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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