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NCT02446730 Clinical Trial

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

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02446730
Other study ID # BEAUTY-II
Secondary ID
Status Recruiting
Phase Phase 4
First received May 6, 2015
Last updated May 15, 2015
Start date September 2014
Est. completion date August 2017

Study information
Verified date May 2015
Source Chonnam National University Hospital
Contact Myung-Ho Jeong, PhD
Phone +82-062-220-5114
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1400
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• BES (biodegradable polymer biolimus-eluting stent)
BES implantation
Drug:
• Prasugel

• Clopidogrel

Locations
Country Name City State
Korea, Republic of Jung-Me Lee Pusan

Sponsors (1)
Lead Sponsor Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary A compoiste of cardiac death, non-fatal myocardiac infarction and stroke within the 1 year after BIOMATRIXTM Stent implantation No
Secondary All-cause death within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Cardiac death within the 1 year after BIOMATRIXTM Stent implantation No
Secondary non-fatal myocardial infarction within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Stroke within the 1 year after BIOMATRIXTM Stent implantation No
Secondary Target lesion revascularization within the 1 year after BIOMATRIXTM Stent implantation No
Secondary stent thrombosis within the 1 year after BIOMATRIXTM Stent implantation No
Secondary BARC bleeding 2,3,and 5 within the 1 year after BIOMATRIXTM Stent implantation Yes
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