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Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction (AFFECT EV)

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ClinicalTrials.gov Identifier: NCT02931045
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Aleksandra Gasecka, Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE October 10, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE December 30, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Concentration of platelet extracellular vesicles [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02931045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2018)
  • Concentration of extracellular vesicles exposing fibrinogen [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
  • Concentration of extracellular vesicles exposing phosphatidylserine [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
  • Concentration of extracellular vesicles from endothelial cells [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
  • Concentration of extracellular vesicles from leukocytes [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2016)
Concentration C-reactive protein, interleukin-6, elastase [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
Official Title  ICMJE Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
Brief Summary Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors are essential for platelet activation. Antagonists against the P2Y12 receptor, which are established in secondary prevention of myocardial infarction, have unexplained anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced infection-related mortality compared to clopidogrel, previous standard treatment for patients with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant platelet extracellular vesicles. The investigators assume that decrease in infection-related mortality in patients treated with ticagrelor may be explained by greater inhibition of the release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected to identify an additional mechanism of action of ticagrelor, which might contribute to the observed clinical benefits in patients treated with ticagrelor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Ticagrelor
    Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
    Other Name: Brillique
  • Drug: Clopidogrel
    Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
    Other Name: Plavix
Study Arms  ICMJE
  • Active Comparator: Ticagrelor
    Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
    Intervention: Drug: Clopidogrel
  • Active Comparator: Clopidogrel
    Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
    Intervention: Drug: Ticagrelor
Publications * Gasecka A, Nieuwland R, van der Pol E, Hajji N, Ćwiek A, Pluta K, Konwerski M, Filipiak KJ. P2Y12 antagonist ticagrelor inhibits the release of procoagulant extracellular vesicles from activated platelets: Preliminary results. Cardiol J. 2018 Apr 19. doi: 10.5603/CJ.a2018.0045. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Informed consent to participate in the study
  • Percutaneous coronary intervention with stent implantation due to first ST-elevation myocardial infarction, or first non ST-elevation myocardial infarction
  • Administration of a loading dose of clopidogrel

Exclusion Criteria:

  • Known coagulopathy
  • Known history of bleeding disorder
  • Suspicion of intracranial haemorrhage
  • Need for oral anticoagulation therapy
  • Administration of glycoprotein (GP) IIb-IIIa antagonists
  • Cardiogenic shock
  • Severe chronic renal failure (estimated glomerular filtration rate [eGFR] < 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Aleksandra Gasecka, MD 0048 22 599 29 58 aleksandra.gasecka@wum.edu.pl
Contact: Krzysztof J. Filipiak, Prof., MD
Listed Location Countries  ICMJE Netherlands,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02931045
Other Study ID Numbers  ICMJE KB/112/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will be presented in a collective form. If a particular study participant presents with an especially high or low concentration of the studied biomarker , the participant's characteristics may be described separately in a way which does not allow to identify the participant's personal data.
Responsible Party Aleksandra Gasecka, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators  ICMJE
Principal Investigator: Aleksandra Gasecka, MD 1st Chair and Department of Cardiology, Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP