NCT06177587Completed
Multimarker Evaluation of Platelet Activity and Agregation in ACS
Multimarker Evaluation of Platelet Activity and Agregation in Patients Presenting With Acute Coronary Syndrome: Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 20 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 8 Dec 2023
- Start date
- 1 Dec 2017
- Primary completion date
- 1 Dec 2022
- Lead sponsor
- Medical University of Warsaw
- Diseases
- Coronary artery disease
- NCT number
- NCT06177587
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 1 Dec 2017 to the primary completion date, 1 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Enrollment in another investigational device or drug study.
Other illness
- Active bleeding;
- Known hypersensitivity or contraindication to ASA, clopidogrel, ticagrelor or prasugrel;
Lab values
- Severe anemia (hemoglobin \< 8g/dL);
- Platelet count ≤70x10\^3/ml;
- Renal failure (hemodialysis or creatinine clearance ≤ 30 ml/min calculated with Cockroft-Gault formula);
Other
- Unstable clinical status (hemodynamic or electrical instability);
- Hematocrit of \< 30% or \> 52%
- Severe hepatic dysfunction (baseline alanine aminotransferase ≥ 2.5 times the upper limit of normal);
- Under judicial protection, tutorship or curatorship;
- Pregnancy;
- Unable to understand and follow study-related instructions;
- Unable to provide an informed consent.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| I Department and Clinic of Cardiology, Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.