NCT03418974

Brief Summary

This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.

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
10,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

November 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

4.2 years

First QC Date

January 14, 2018

Last Update Submit

January 31, 2018

Conditions

Dyslipidemias

Keywords

DyslipidemiaCardiovascular DiseasesHypertensionLDL-C

Outcome Measures

Primary Outcomes (1)

  • LDL-C target achieving rate

    To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.

    3 months

Secondary Outcomes (10)

  • Blood lipid parameters

    3 months

  • Blood lipid parameters

    3 months

  • Blood lipid parameters

    3 months

  • Blood glucose levels

    1 year

  • Fasting blood glucose

    1 year

  • +5 more secondary outcomes

Study Arms (3)

Pitavastatin treatment

EXPERIMENTAL

The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd..

Drug: Pitavastatin

Atorvastatin treatment

EXPERIMENTAL

The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.

Drug: Atorvastatin

Rosuvastatin treatment

EXPERIMENTAL

The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified.

Drug: Rosuvastatin

Interventions

PitavastatinDRUG

Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.

Pitavastatin treatment
AtorvastatinDRUG

Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.

Atorvastatin treatment
RosuvastatinDRUG

Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.

Rosuvastatin treatment

Eligibility Criteria

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

You may qualify if:

  • Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
  • ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;

You may not qualify if:

  • Patients with any allergy to statins;
  • ACS patients in acute stage；
  • Patients with severe liver disease or biliary obstruction；
  • Patients taking cyclosporine；
  • Patients who have being treated with statins currently or in the past;
  • Pregnant or lactating women and those women who planning to be pregnant;
  • Immunodeficiency or Immunocompromised patients;
  • Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
  • Patients using systemic hormone drug;
  • Researchers decided that the patients who was not suitable to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heart Center of Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

DyslipidemiasCardiovascular DiseasesHypertension

Interventions

pitavastatinAtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Yuming Jin, Professor

    School of Public Health，Fudan University

    PRINCIPAL INVESTIGATOR

  • Dayi Hu, Professor

    Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of School of Public Health, Fudan University

Study Record Dates

First Submitted

January 14, 2018

First Posted

February 1, 2018

Study Start

November 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)