NCT02446730

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

May 6, 2015

Last Update Submit

May 15, 2015

Conditions

Cardiac DeathHemorrhageCerebrovascular AccidentMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

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

    within the 1 year after BIOMATRIXTM Stent implantation

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

BES with Prasugel 5mg

ACTIVE COMPARATOR

Biolimus-eluting stent with Prasugrel 5mg once daily MD

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

BES with Clopidogrel 75mg

ACTIVE COMPARATOR

Biolimus-eluting stent with Clopidogrel 75mg once daily MD

Device: BES (biodegradable polymer biolimus-eluting stent)Drug: Clopidogrel

Interventions

BES (biodegradable polymer biolimus-eluting stent)DEVICE

BES implantation

Also known as: BiomatirxTM, Biomatrix FlexTM
BES with Clopidogrel 75mgBES with Prasugel 5mg
PrasugelDRUG
BES with Prasugel 5mg
ClopidogrelDRUG
BES with Clopidogrel 75mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung-Me Lee

Pusan, South Korea

RECRUITING

MeSH Terms

Conditions

DeathHemorrhageStrokeMyocardial Infarction

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Myung Ho Jeong, PhD

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myung-Ho Jeong, PhD

CONTACT

+82-062-220-5114

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 18, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations

KR(1)