Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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ST-Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prasugrel 60 mg

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

Group Type EXPERIMENTAL

Prasugrel 60 mg

Intervention Type DRUG

Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.

Ticagrelor 180 mg

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

Group Type EXPERIMENTAL

Ticagrelor 180 mg

Intervention Type DRUG

Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.

Interventions

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Prasugrel 60 mg

Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.

Intervention Type DRUG

Ticagrelor 180 mg

Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.

Intervention Type DRUG

Other Intervention Names

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Effient 60 mg Brilinta 180 mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No