Status:
COMPLETED
Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction
Lead Sponsor:
University of Zagreb
Collaborating Sponsors:
Croatian Science Foundation
Clinical Hospital Centre Zagreb
Conditions:
Acute Coronary Syndrome
STEMI
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 outco...
Detailed Description
In this study we plan to continue our previous research on individualized approach to platelet aniaggregation therapy in patients with an ACS treated with a PCI. The subjects included in this study wi...
Eligibility Criteria
Inclusion
- STEMI
- NSTEMI
- Unstable Angina
- Successful PCI
- Signed informed consent
Exclusion
- \>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
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04369534
Start Date
December 1 2015
End Date
December 1 2019
Last Update
April 30 2020
Active Locations (1)
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1
Uhiversity hospital Center Zagreb
Zagreb, Croatia, 10000