Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
NCT ID: NCT02931045
Last Updated: 2020-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2017-12-30
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Ticagrelor
Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
Ticagrelor
Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
Clopidogrel
Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
Clopidogrel
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Interventions
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Ticagrelor
Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
Clopidogrel
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent to participate in the study
* Percutaneous coronary intervention with stent implantation due to first S T elevation myocardial infarction, or first non S T -elevation myocardial infarction
* Administration of a loading dose of clopidogrel
Exclusion Criteria
* Known history of bleeding disorder
* Suspicion of intracranial haemorrhage
* Need for oral anticoagulation therapy
* Administration of glycoprotein (GP) II b - III a antagonists
* Cardiogenic shock
* Severe chronic renal failure (estimated glomerular filtration rate \< 30 mL/min)
* Severe liver insufficiency
* Chronic dyspnea
* Increased risk of bradycardia
* Autoimmune disease
* Infectious disease
* Neoplasms
* Pregnancy
* Study drug intolerance
* Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors
* Participation in any previous study with ticagrelor or clopidogrel
18 Years
ALL
Yes
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Medical University of Warsaw
OTHER
Responsible Party
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Aleksandra Gasecka
Medical Doctor
Principal Investigators
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Aleksandra Gasecka, MD
Role: PRINCIPAL_INVESTIGATOR
1st Chair and Department of Cardiology, Medical University of Warsaw
Locations
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Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam
Amsterdam, , Netherlands
1st Chair and Department of Cardiology, Medical University of Warsaw
Warsaw, , Poland
Countries
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References
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Gasecka A, Nieuwland R, van der Pol E, Hajji N, Cwiek A, Pluta K, Konwerski M, Filipiak KJ. P2Y12 antagonist ticagrelor inhibits the release of procoagulant extracellular vesicles from activated platelets. Cardiol J. 2019;26(6):782-789. doi: 10.5603/CJ.a2018.0045. Epub 2018 Apr 19.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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KB/112/2016
Identifier Type: -
Identifier Source: org_study_id