Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Dong-A University

Status and phase: Terminated; Phase 3

Conditions: ST-Segment Elevation Myocardial Infarction

Treatments: Drug: Prasugrel 60 mg; Drug: Ticagrelor 180 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02075125

PANTASTIC

Details and patient eligibility

About

To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Full description

Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.

Enrollment: 39 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ST-segment elevation myocardial infarction
• Undergoing primary percutaneous coronary intervention
• Aged between 20 and 80 years

Exclusion criteria

• Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor)
• History of stroke or transient ischemic attack
• Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count < 100,000/mm3 or hemoglobin < 10 g/dl
• Chronic oral anticoagulation treatment
• Contraindication to the antiplatelet treatment
• Severe renal insufficiency (serum creatine>2.5 mg/dl)
• Severe hepatic dysfunction (serum liver enzyme or bilirubin>3 times normal limit)
• Sever chronic obstructive pulmonary disease (COPD) or bradycardia
• Body weight < 50 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Prasugrel 60 mg

Experimental group

Description:

Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose

Treatment:

Drug: Prasugrel 60 mg

Ticagrelor 180 mg

Experimental group

Description:

Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose

Treatment:

Drug: Ticagrelor 180 mg