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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myocardial Infarction focused on measuring extracellular vesicles, inflammation, thrombosis, antiplatelet drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam
  • 1st Chair and Department of Cardiology, Medical University of Warsaw

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)

Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)

Outcomes

Primary Outcome Measures

Concentration of Platelet Extracellular Vesicles/ml
Concentration of platelet extracellular vesicles/ml measured with flow cytometry

Secondary Outcome Measures

Concentration of Extracellular Vesicles Exposing Fibrinogen
Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry
Concentration of Extracellular Vesicles Exposing Phosphatidylserine
Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry
Concentration of Extracellular Vesicles From Endothelial Cells
The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry
Concentration of Extracellular Vesicles From Leukocytes
Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry

Full Information

First Posted
October 10, 2016
Last Updated
November 28, 2020
Sponsor
Medical University of Warsaw
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02931045
Brief Title
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
Acronym
AFFECT EV
Official Title
Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
extracellular vesicles, inflammation, thrombosis, antiplatelet drugs

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Active Comparator
Arm Description
Ticagrelor: oral, 180 mg once (loading dose) followed by 90 mg twice daily (maintenance dose)
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel: oral, 300 mg or 600 mg once (loading dose) followed by 75 mg once daily (maintenance dose)
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brilique
Intervention Description
Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Primary Outcome Measure Information:
Title
Concentration of Platelet Extracellular Vesicles/ml
Description
Concentration of platelet extracellular vesicles/ml measured with flow cytometry
Time Frame
6 months following the beginning of antiplatelet therapy
Secondary Outcome Measure Information:
Title
Concentration of Extracellular Vesicles Exposing Fibrinogen
Description
Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry
Time Frame
6 months
Title
Concentration of Extracellular Vesicles Exposing Phosphatidylserine
Description
Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry
Time Frame
6 months
Title
Concentration of Extracellular Vesicles From Endothelial Cells
Description
The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry
Time Frame
6 months
Title
Concentration of Extracellular Vesicles From Leukocytes
Description
Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Gasecka, MD
Organizational Affiliation
1st Chair and Department of Cardiology, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
1st Chair and Department of Cardiology, Medical University of Warsaw
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
29671861
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29398917
Description
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Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

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