Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

NCT ID: NCT02931045

Last Updated: 2020-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-30

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Keywords

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extracellular vesicles inflammation thrombosis antiplatelet drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Ticagrelor

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

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Comparison of ticagrelor with another antiplatelet drug (clopidogrel)

Clopidogrel

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

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Comparison of clopidogrel with another antiplatelet drug (ticagrelor)

Interventions

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Ticagrelor

Comparison of ticagrelor with another antiplatelet drug (clopidogrel)

Intervention Type DRUG

Clopidogrel

Comparison of clopidogrel with another antiplatelet drug (ticagrelor)

Intervention Type DRUG

Other Intervention Names

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Brilique Plavix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Gasecka

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandra Gasecka, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Amsterdam, , Netherlands

Site Status

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

Warsaw, , Poland

Site Status

Countries

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Netherlands Poland

References

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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.

Reference Type BACKGROUND
PMID: 29671861 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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KB/112/2016

Identifier Type: -

Identifier Source: org_study_id