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

November 28, 2020 updated by: Aleksandra Gasecka, Medical University of Warsaw

Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months following the beginning of antiplatelet therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Extracellular Vesicles Exposing Fibrinogen
Time Frame: 6 months
Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry
6 months
Concentration of Extracellular Vesicles Exposing Phosphatidylserine
Time Frame: 6 months
Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry
6 months
Concentration of Extracellular Vesicles From Endothelial Cells
Time Frame: 6 months
The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry
6 months
Concentration of Extracellular Vesicles From Leukocytes
Time Frame: 6 months
Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Aleksandra Gasecka, MD, 1st Chair and Department of Cardiology, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

November 28, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/112/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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