Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

— AFFECT EV  

Official title:

Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931045
• Other study ID #: KB/112/2016
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blister
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ticagrelor
Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
• Clopidogrel
Comparison of clopidogrel with another antiplatelet drug (ticagrelor)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Netherlands,  Poland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concentration of Extracellular Vesicles Exposing Fibrinogen	Concentration of extracellular vesicles exposing fibrinogen/ ml measured with flow cytometry	6 months
Secondary	Concentration of Extracellular Vesicles Exposing Phosphatidylserine	Concentration of extracellular vesicles exposing phosphatidylserine/ml measured with flow cytometry	6 months
Secondary	Concentration of Extracellular Vesicles From Endothelial Cells	The concentrations of extracellular vesicles from endothelial cells/ ml measured with flow cytometry	6 months
Secondary	Concentration of Extracellular Vesicles From Leukocytes	Concentration of extracellular vesicles from leukocytes/ ml measured with flow cytometry	6 months

External Links

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