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

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zagreb
• Collaborators: Clinical Hospital Centre Zagreb; Croatian Science Foundation
• Treatments: Clopidogrel; Ticagrelor

Criteria

Inclusion Criteria:

• STEMI

• NSTEMI

• Unstable Angina

• Successful PCI

• Signed informed consent

Exclusion Criteria:

• >80 years of age at time of inclusion

• Cardiogenic shock

• Unsuccessful PCI

• GI bleed within the last 6 months

• Hemorrhagic CVI within last 6 months

• Ischemic CVI within last 6 months

• Major surgery within last 6 months

• Malignant disease

• Platelet count <=150

• Hematocrit <=30% or >=52%

• Creatinine >=200

• Chronic anticoagulant therapy

• Thrombotic thrombocytopenic purpura, leukemia, myelodysplasia

• Other: did not sign informed consent, refused, lives far away, leading physician doesn't want the patient to take part or any other reason leading to not signing the informed consent