Cardiac DeathPhase 4BEAUTY-IINCT02446730
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
A Phase 4 study testing BES (biodegradable polymer biolimus-eluting stent), Prasugel and Clopidogrel in people with Cardiac Death and Hemorrhage, run by Chonnam National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Death, Hemorrhage, Cerebrovascular Accident
- What is being tested?
- BES (biodegradable polymer biolimus-eluting stent), Prasugel and Clopidogrel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Myung-Ho Jeong, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Jung-Me Lee
Pusan
Myung-Ho, Jeong, +82-62-220-5114
About this study
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
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.
Read the 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.
- Being tested
- BES (biodegradable polymer biolimus-eluting stent), Prasugel, Clopidogrel
- Medical subject headings
- Death, Hemorrhage, Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BES (biodegradable polymer biolimus-eluting stent)Device
Also called BiomatirxTM, Biomatrix FlexTM
BES implantation
PrasugelDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| BES with Prasugel 5mg | Active comparator | Biolimus-eluting stent with Prasugrel 5mg once daily MD Receives: Device: BES (biodegradable polymer biolimus-eluting stent); Drug: Prasugel |
| BES with Clopidogrel 75mg | Active comparator | Biolimus-eluting stent with Clopidogrel 75mg once daily MD Receives: Device: BES (biodegradable polymer biolimus-eluting stent); Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke
Measured: within the 1 year after BIOMATRIXTM Stent implantation
Secondary outcomes (7)
All-cause death
Measured: within the 1 year after BIOMATRIXTM Stent implantation
Cardiac death
Measured: within the 1 year after BIOMATRIXTM Stent implantation
non-fatal myocardial infarction
Measured: within the 1 year after BIOMATRIXTM Stent implantation
Stroke
Measured: within the 1 year after BIOMATRIXTM Stent implantation
Target lesion revascularization
Measured: within the 1 year after BIOMATRIXTM Stent implantation
stent thrombosis
Measured: within the 1 year after BIOMATRIXTM Stent implantation
BARC bleeding 2,3,and 5
Measured: within the 1 year after BIOMATRIXTM Stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Ho Jeong, Chonnam National University Hospital
- Investigators
- Myung Ho Jeong, PhD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446730
- Sponsor's protocol ID
- BEAUTY-II
- Acronym
- BEAUTY-II
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02446730
- Acronym / sponsor ID
- BEAUTY-II / BEAUTY-II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BES with Prasugel 5mg | Active comparator | Device: BES (biodegradable polymer biolimus-eluting stent), Drug: PrasugelBiolimus-eluting stent with Prasugrel 5mg once daily MD |
| BES with Clopidogrel 75mg | Active comparator | Device: BES (biodegradable polymer biolimus-eluting stent), Drug: ClopidogrelBiolimus-eluting stent with Clopidogrel 75mg once daily MD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BES (biodegradable polymer biolimus-eluting stent)Also: BiomatirxTM, Biomatrix FlexTMBES implantation | Device | BES with Clopidogrel 75mg, BES with Prasugel 5mg |
| Prasugel | Drug | BES with Prasugel 5mg |
| Clopidogrel | Drug | BES with Clopidogrel 75mg |
Primary outcome
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
7 secondary outcomes
All-cause death
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Cardiac death
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
non-fatal myocardial infarction
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Stroke
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Target lesion revascularization
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
stent thrombosis
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
BARC bleeding 2,3,and 5
Time frame: within the 1 year after BIOMATRIXTM Stent implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung-Ho Jeong, PhD contact
Myung Ho Jeong, PhD principal investigator
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BES (biodegradable polymer biolimus-eluting stent), Prasugel and Clopidogrel in people with Cardiac Death and Hemorrhage, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ho Jeong, PhD (+82-062-220-5114), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A compoiste of cardiac death, non-fatal myocardiac infarction and stroke (time frame: within the 1 year after BIOMATRIXTM Stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.