Acute Coronary Syndrome Clinical Trial
— SPARELIFEOfficial title:
Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction
Verified date | April 2020 |
Source | University of Zagreb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 1, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Uhiversity hospital Center Zagreb | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University of Zagreb | Clinical Hospital Centre Zagreb, Croatian Science Foundation |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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