Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02931045
• Date of registration: 10/10/2016
• Prospective Registration: Yes
• Primary sponsor: Medical University of Warsaw
• Public title: Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction AFFECT EV
• Scientific title: Antiplatelet Therapy Effect on Platelet Extracellular Vesicles in Acute Myocardial Infarction
• Date of first enrolment: December 30, 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02931045
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Netherlands, Poland

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Informed consent to participate in the study

- Percutaneous coronary intervention with stent implantation due to first ST-elevation
myocardial infarction, or first non ST-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) IIb-IIIa antagonists

- Cardiogenic shock

- Severe chronic renal failure (estimated glomerular filtration rate [eGFR] < 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Drug: Ticagrelor

Drug: Clopidogrel

Primary Outcome(s)

Concentration of platelet extracellular vesicles [Time Frame: 6 months following the beginning of antiplatelet therapy]

Secondary Outcome(s)

Concentration of extracellular vesicles exposing phosphatidylserine [Time Frame: 6 months following the beginning of antiplatelet therapy]

Concentration of extracellular vesicles from endothelial cells [Time Frame: 6 months following the beginning of antiplatelet therapy]

Concentration of extracellular vesicles exposing fibrinogen [Time Frame: 6 months following the beginning of antiplatelet therapy]

Concentration of extracellular vesicles from leukocytes [Time Frame: 6 months following the beginning of antiplatelet therapy]

Secondary ID(s)

KB/112/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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