Status:
COMPLETED
Multimarker Evaluation of Platelet Activity and Agregation in ACS
Lead Sponsor:
Medical University of Warsaw
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
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. ...
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 ...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
- Unable to provide an informed consent.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06177587
Start Date
December 1 2017
End Date
December 8 2023
Last Update
December 20 2023
Active Locations (1)
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1
I Department and Clinic of Cardiology, Medical University of Warsaw
Warsaw, Poland, 00-001