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
• 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

• Acute Coronary Syndrome
• Cardiac Death
• Cerebrovascular Accident
• Hemorrhage
• Myocardial Infarction
• Stroke

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