NCT04270344

Brief Summary

Prospective Observation study to identify the rate of MACE in AMI with Livalo V(Pitavastatin/Valsartan) for 12 month in Korea

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
905

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

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

July 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

February 12, 2020

Last Update Submit

April 11, 2021

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality, non-fatal MI, repeat re-vascularization

    MACE

    12 months

Secondary Outcomes (11)

  • The rate of mortality

    6 and 12 months

  • The rate of cardiac death

    6 and 12 months

  • The rate of nonfatal MI

    6 and 12 months

  • The rate of hospitalization due to heart failure

    6 and 12 months

  • The rate of Coronary artery bypass graft(CABG)

    6 and 12 months

  • +6 more secondary outcomes

Interventions

Pitavastatin 4mgDRUG

combination therapy with pitavastatin/valsartan (LivaloV)

Also known as: valsartan

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hypercholesterolemia and AMI

You may qualify if:

  • idiopathic hypercholesterolemia (heterogeneous familial and non-familial, Fredrickson type IIa) or mixed-type (Fredrickson type IIb) with AMI (STEMI, NSTEMI), including essential hypertension or heart failure
  • diagnosed AMI (STEMI, NSTEMI) 1 months ago
  • more than 19 years old and more than 2 years of life expectancy at screening
  • informed consent

You may not qualify if:

  • cardiogenic shock or corresponding clinical events
  • contraindicated to the IP
  • unsuitable to this study judged by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JWP

Seoul, Seocho-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

pitavastatinValsartan

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Myungho Jeong, Professor

    Chonnam National University Hospital

    STUDY CHAIR

Central Study Contacts

Myungho Jeong, Professor

CONTACT

82-62-220-6243myungho@chol.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

July 1, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

KR(1)