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

Primary Purpose

Cardiac Death, Hemorrhage, Cerebrovascular Accident

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BES (biodegradable polymer biolimus-eluting stent)

Prasugel

Clopidogrel

About this trial

This is an interventional treatment trial for Cardiac Death

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Jung-Me LeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

BES with Prasugel 5mg

BES with Clopidogrel 75mg

Arm Description

Biolimus-eluting stent with Prasugrel 5mg once daily MD

Biolimus-eluting stent with Clopidogrel 75mg once daily MD

Outcomes

Primary Outcome Measures

A compoiste of cardiac death, non-fatal myocardiac infarction and stroke

Secondary Outcome Measures

All-cause death

Cardiac death

non-fatal myocardial infarction

Stroke

Target lesion revascularization

stent thrombosis

BARC bleeding 2,3,and 5

Full Information

NCT ID

NCT02446730

First Posted

May 6, 2015

Last Updated

May 15, 2015

Sponsor

Chonnam National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02446730

Brief Title

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

Acronym

BEAUTY-II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chonnam National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Death, Hemorrhage, Cerebrovascular Accident, Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BES with Prasugel 5mg

Arm Type

Active Comparator

Arm Description

Biolimus-eluting stent with Prasugrel 5mg once daily MD

Arm Title

BES with Clopidogrel 75mg

Arm Type

Active Comparator

Arm Description

Biolimus-eluting stent with Clopidogrel 75mg once daily MD

Intervention Type

Device

Intervention Name(s)

BES (biodegradable polymer biolimus-eluting stent)

Other Intervention Name(s)

BiomatirxTM, Biomatrix FlexTM

Intervention Description

BES implantation

Intervention Type

Drug

Intervention Name(s)

Prasugel

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Primary Outcome Measure Information:

Title

A compoiste of cardiac death, non-fatal myocardiac infarction and stroke

Time Frame