MedTrace Logo

Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction

NCT04369534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-04-30

No results posted yet for this study

Summary

The specific goal of this study is to determine whether the individualized approach and adjusting the dosage of the P2Y12 receptor inhibitors will improve the platelet inhibiton and the clinical outcome in patients with an ACS, that were treated with PCI and the aforementioned drugs, but with an increased initial residual platelet activity. It is expected that the patients that have undergone the P2Y12 inhibitor therapy adjustment (according to the platelet reactivity measured by POC devices) will have better clinical outcomes (ie less ischemic events, without a significant increase in bleeding events) than those who did not undergo the therapy adjustment.

Conditions

  • Acute Coronary Syndrome
  • STEMI
  • NSTEMI - Non-ST Segment Elevation MI
  • PLATELET AGGREGATION
  • INDIVIDUALIZED THERAPY

Interventions

DRUG

Clopidogrel

Adjusting clopidogrel dosage according to platelet reactivity results during 12 months after PCI

DRUG

Ticagrelor

Administration of standard dose of ticagrelor during 12 months after PCI

Sponsors & Collaborators

  • Croatian Science Foundation

    collaborator OTHER_GOV

  • Clinical Hospital Centre Zagreb

    collaborator OTHER

  • University of Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2019-11-30
Completion
2019-12-01

Countries

  • Croatia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04369534 on ClinicalTrials.gov