Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome (BEAUTY-II)

A Prospective, Multicenter, Randomized, Open-label Trial to Evaluate Efficacy and Safety of 5mg Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Who Underwent Percutaneous Coronary Intervention With BiomatrixTM Stent

The purpose of this study is to evaluate the efficacy and safety of 5mg maintenance dose (MD) of prasugrel in patients with acute myocardial infarction (AMI) who underwent percutaneous coronary intervention (PCI) with BiomatrixTM stent.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Hemorrhage; Cerebrovascular Accident; Cardiac Death
• Intervention / Treatment: Drug: Clopidogrel; Device: BES (biodegradable polymer biolimus-eluting stent); Drug: Prasugel

Detailed Description

About 1400 patients derived from Korean patients with acute coronary syndrome (ACS) receiving percutaneous coronary intervention (PCI) with BES(Biolimus-eluting stent, BiomatrixTM) in a routine manner will be enrolled in the investigators trial.

These patients will be randomized 1:1 to either prasugrel 5mg once daily MD or clopidogrel 75mg once daily MD after successful PCI with BES .

The investigators excluded the patients with age ≥75 years, body weight <60 kg, or history of TIA (transient ischemic attack) or stroke. Follow-up data will be collected until 1-year after index procedure.

Primary efficacy end-point defined as the composite of cardiac death, non-fatal MI, stent thrombosis and ischemic driven target vessel revascularization and safety end-points as BARC (the Bleeding Academic Research Consortium) type ≥ 2 bleeding.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Myung-Ho Jeong, PhD; Phone Number: +82-062-220-5114

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Recruiting
    • Jung-Me Lee
    • Contact: Myung-Ho, Jeong; Phone Number: +82-62-220-5114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who can undergo percutaneous coronary intervention with Biomatrix stent with no history of TIA or stroke,
• 75 years old or younger,
• body weight of 60 kg or more and diagnosed with acute coronary syndrome

Exclusion Criteria:

• Patients with history of TIA or stroke,
• 75 years old or older,
• body weight of 60 kg or under,
• hypersensitivity to or contraindicated for heparin, aspirin, clopidogrel, prasugrel or contrast media

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BES with Prasugel 5mg; Biolimus-eluting stent with Prasugrel 5mg once daily MD	Device: BES (biodegradable polymer biolimus-eluting stent); BES implantation; Other Names: BiomatirxTM; Biomatrix FlexTM; Drug: Prasugel
Active Comparator: BES with Clopidogrel 75mg; Biolimus-eluting stent with Clopidogrel 75mg once daily MD	Drug: Clopidogrel; Device: BES (biodegradable polymer biolimus-eluting stent); BES implantation; Other Names: BiomatirxTM; Biomatrix FlexTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke	within the 1 year after BIOMATRIXTM Stent implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause death	within the 1 year after BIOMATRIXTM Stent implantation
Cardiac death	within the 1 year after BIOMATRIXTM Stent implantation
non-fatal myocardial infarction	within the 1 year after BIOMATRIXTM Stent implantation
Stroke	within the 1 year after BIOMATRIXTM Stent implantation
Target lesion revascularization	within the 1 year after BIOMATRIXTM Stent implantation
stent thrombosis	within the 1 year after BIOMATRIXTM Stent implantation
BARC bleeding 2,3,and 5	within the 1 year after BIOMATRIXTM Stent implantation

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Myung Ho Jeong, PhD, Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Estimate): May 18, 2015
• Last Update Submitted That Met QC Criteria: May 15, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Myocardial Infarction; Infarction; Stroke; Death; Hemorrhage; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: BEAUTY-II