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

NCT04369534 | Completed Phase 4

• 1 other identifier: 8403
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Incidence of ischemic events

  rehospitalization due to myocardial ishemia, another PCI, non-fatal acute myocardial infarction, "in-stent" thrombosis, transient ischemic attack (TIA), cerebrovascular insult (CVI) and cardiovascular death

  During 1 year of follow up

• Incidence of Hemorrhagic events

  Hemorrhagic events will be classified according to the BARC system, which represents an international consensus on documenting and classifying these events in cardiologic studies.

  During 1 year of follow up

• MACCE

  Data concerning mortality and other adverse cardiac and cerebrovascular events (MACCE) will be verified by examining the medical records. If no other cause of death was verified or documented, each fatal event will be regarded as being of cardiac etiology.

  During 1 year of follow up

Study Arms (2)

First group

ACTIVE COMPARATOR

The patients randomized into the first group will be given the newer P2Y12 receptor inhibitor ticagrelor during the 12 months.

Drug: Ticagrelor

Second group

ACTIVE COMPARATOR

The second group of patients will be given ticagrelor initially, and after the first 30 days it will be replaced with clopidogrel, that will be given for the remaining time period (up to 12 months). Clopidogrel dosing will be modified according to the results of the aggregometry using the ADP test.

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

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

Second group

Ticagrelor DRUG

Administration of standard dose of ticagrelor during 12 months after PCI

First group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI
• NSTEMI
• Unstable Angina
• Successful PCI
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead
• Croatian Science Foundation: collaborator
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

Uhiversity hospital Center Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Davor Milicic, MD, PhD

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: December 1, 2015
• Primary Completion: November 30, 2019
• Study Completion: December 1, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)