Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction (AFFECT EV)

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Clopidogrel; Drug: Ticagrelor

Study type: Interventional

Funder types: Other

Identifiers

NCT02931045

KB/112/2016

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Ticagrelor

Active Comparator group

Description:

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

Treatment:

Drug: Ticagrelor

Clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel