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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931045
Recruitment Status : Completed
First Posted : October 12, 2016
Results First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Aleksandra Gasecka, Medical University of Warsaw

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Ticagrelor Drug: Clopidogrel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
Actual Study Start Date : December 30, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ticagrelor
Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
 Drug: Ticagrelor
Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
Other Name: Brilique
Active Comparator: Clopidogrel
Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
 Drug: Clopidogrel
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Other Name: Plavix


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of Platelet Extracellular Vesicles/ml [ Time Frame: 6 months following the beginning of antiplatelet therapy ]
    Concentration of platelet extracellular vesicles/ml measured with flow cytometry


Secondary Outcome Measures :
  1. Concentration of Extracellular Vesicles Exposing Fibrinogen [ Time Frame: 6 months ]
    Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry

  2. Concentration of Extracellular Vesicles Exposing Phosphatidylserine [ Time Frame: 6 months ]
    Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry

  3. Concentration of Extracellular Vesicles From Endothelial Cells [ Time Frame: 6 months ]
    The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry

  4. Concentration of Extracellular Vesicles From Leukocytes [ Time Frame: 6 months ]
    Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 years
  • 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 coagulopathy
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931045


Locations
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Netherlands
Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam
Amsterdam, Netherlands
Poland
1st Chair and Department of Cardiology, Medical University of Warsaw
Warsaw, Poland
Sponsors and Collaborators
Medical University of Warsaw
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Aleksandra Gasecka, MD 1st Chair and Department of Cardiology, Medical University of Warsaw
  Study Documents (Full-Text)

Documents provided by Aleksandra Gasecka, Medical University of Warsaw:
Study Protocol and Statistical Analysis Plan  [PDF] December 21, 2016

More Information
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Additional Information:

Publications:

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Responsible Party: Aleksandra Gasecka, Medical Doctor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02931045    
Other Study ID Numbers: KB/112/2016
First Posted: October 12, 2016    Key Record Dates
Results First Posted: December 23, 2020
Last Update Posted: December 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleksandra Gasecka, Medical University of Warsaw:
extracellular vesicles
inflammation
thrombosis
antiplatelet drugs
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs