Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

NCT02931045 | Completed Phase 4 Results

• 1 other identifier: KB/112/2016
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Myocardial Infarction

Keywords

extracellular vesicles; inflammation; thrombosis; antiplatelet drugs

Outcome Measures

Primary Outcomes (1)

• Concentration of Platelet Extracellular Vesicles/ml

  Concentration of platelet extracellular vesicles/ml measured with flow cytometry

  6 months following the beginning of antiplatelet therapy

Secondary Outcomes (4)

• Concentration of Extracellular Vesicles Exposing Fibrinogen

  6 months

• Concentration of Extracellular Vesicles Exposing Phosphatidylserine

  6 months

• Concentration of Extracellular Vesicles From Endothelial Cells

  6 months

• Concentration of Extracellular Vesicles From Leukocytes

  6 months

Study Arms (2)

Ticagrelor

ACTIVE COMPARATOR

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

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Comparison of ticagrelor with another antiplatelet drug (clopidogrel)

Also known as: Brilique

Ticagrelor

Clopidogrel DRUG

Comparison of clopidogrel with another antiplatelet drug (ticagrelor)

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (2)

Laboratory of Experimental Clinical Chemistry, Academic Medical Centre of the University of Amsterdam

Amsterdam, Netherlands

Location

1st Chair and Department of Cardiology, Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 29671861 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Myocardial Infarction; Inflammation; Thrombosis

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Aleksandra Gasecka, MD, PhD
• Organization: 1st Chair and Department of Cardiology, Medical University of Warsaw

alesandra.gasecka@wum.edu.pl

+48225991951

Study Officials

• Aleksandra Gasecka, MD

  1st Chair and Department of Cardiology, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: December 30, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2019
• Last Updated: December 23, 2020
• Results First Posted: December 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PL (1)