Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Phase 3

Terminated

Conditions: ST-Segment Elevation Myocardial Infarction

Interventions: Drug: Ticagrelor 180 mg
Drug: Prasugrel 60 mg

Registration Number: NCT02075125

Lead Sponsor: Dong-A University

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

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor 180 mg	Ticagrelor 180 mg	Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Prasugrel 60 mg	Prasugrel 60 mg	Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose

Primary Outcome Measures

Name	Time	Method
Number of Participants With High Platelet Reactivity	48 hours after loading dose of study drug	Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events	30 days	Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.
Bleeding Event	30 days	Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
Adverse Drug Reaction	30 days	Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.
Pre-procedure P2Y12 Reaction Units (PRU)	Baseline	Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).
Number of Participants With Low Platelet Reactivity	48 hours after loading dose of study drug	Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) \<85 and platelet reactivity index (PRI)\<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.
Pre-procedure Platelet Reactivity Index (PRI)	Baseline	Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).