Multimarker Evaluation of Platelet Activity and Agregation in ACS

NCT06177587 | Completed

• 1 other identifier: MULTIMARKER-ACS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Biomarkers; IPF; Immature Platelet Fraction; ADP test; Antiplatelet therapy

Outcome Measures

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.

  50 months

Study Arms (2)

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

Assesment of biomarkers in acute coronary syndromes OTHER

Collection of 20ml of blood from peripheral vein.

Assesment of platelet biomarkers in acute coronary syndromes - high level of parameters; Assesment of platelet biomarkers in acute coronary syndromes - low level of parameters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

I Department and Clinic of Cardiology, Medical University of Warsaw

Warsaw, 00-001, Poland

Location

Related Publications (3)

• 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.

  PMID: 38202070 DERIVED

• 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.

  PMID: 38196286 DERIVED

• 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.

  PMID: 38126718 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomaniak Mariusz MD PhD

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 8, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

PL (1)