Phase 4
N=60
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT02931045 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Dec 2020
Primary outcome: Primary: Concentration of Platelet Extracellular Vesicles/ml — 2690000; 4310000 Platelet Extracellular Vesicles/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Warsaw
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Platelet Extracellular Vesicles/ml |
2690000; 4310000 | — |
| SECONDARY Concentration of Extracellular Vesicles Exposing Fibrinogen |
— | — |
| SECONDARY Concentration of Extracellular Vesicles Exposing Phosphatidylserine |
— | — |
| SECONDARY Concentration of Extracellular Vesicles From Endothelial Cells |
— | — |
| SECONDARY Concentration of Extracellular Vesicles From Leukocytes |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02931045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.