MedDataX Logo

Multimarker Evaluation of Platelet Activity and Agregation in ACS

NCT ID: NCT06177587

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Assesment of biomarkers in acute coronary syndromes

Intervention Type OTHER

Collection of 20ml of blood from peripheral vein.

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.

Assesment of biomarkers in acute coronary syndromes

Intervention Type OTHER

Collection of 20ml of blood from peripheral vein.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Assesment of biomarkers in acute coronary syndromes

Collection of 20ml of blood from peripheral vein.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mariusz Tomaniak

Tomaniak Mariusz MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

I Department and Clinic of Cardiology, Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38202070 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38196286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38126718 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MULTIMARKER-ACS

Identifier Type: -

Identifier Source: org_study_id