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Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Primary Purpose

Dyslipidemias

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pitavastatin

Atorvastatin

Rosuvastatin

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.

Exclusion Criteria:

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.

Sites / Locations

Heart Center of Peking University People's Hospital
School of Public Health, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Pitavastatin treatment

Atorvastatin treatment

Rosuvastatin treatment

Arm Description

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..

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

Outcomes

Primary Outcome Measures

LDL-C target achieving rate

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

Secondary Outcome Measures

Blood lipid parameters

The levels of total cholesterol (TC) in mmol/L

Blood lipid parameters

The levels of triglyceride (TG) in mmol/L

Blood lipid parameters

The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L

Blood glucose levels

To measure the level of glycosylated hemoglobin (HbA1) in percent (%)

Fasting blood glucose

The levels of fasting blood glucose (FBG) in mmol/L

Blood lipid parameters

The levels of total cholesterol (TC) in mmol/L

Blood lipid parameters

The levels of triglyceride (TG) in mmol/L

Blood lipid parameters

The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L

Blood lipid parameters

The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study.

Full Information

NCT ID

NCT03418974

First Posted

January 14, 2018

Last Updated

January 31, 2018

Sponsor

Fudan University

Collaborators

Peking University People's Hospital, Jiangsu Wanbang Medicine Marketing Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03418974

Brief Title

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

Official Title

Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

Collaborators

Peking University People's Hospital, Jiangsu Wanbang Medicine Marketing Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Study Objective: The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population; The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients. Study Design: The study was an open-label, multi-center network register-based follow-up study. The total sample size: 10000 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias

Keywords

Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to one of two or more groups in parallel for the duration of the study.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pitavastatin treatment

Arm Type

Experimental

Arm Description

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..

Arm Title

Atorvastatin treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Rosuvastatin treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pitavastatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

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

Primary Outcome Measure Information:

Title

LDL-C target achieving rate

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Blood lipid parameters

Description

The levels of total cholesterol (TC) in mmol/L

Time Frame

3 months

Title

Blood lipid parameters

Description

The levels of triglyceride (TG) in mmol/L

Time Frame

3 months

Title

Blood lipid parameters

Description

The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L

Time Frame

3 months

Title

Blood glucose levels

Description

To measure the level of glycosylated hemoglobin (HbA1) in percent (%)

Time Frame

1 year

Title

Fasting blood glucose

Description

The levels of fasting blood glucose (FBG) in mmol/L

Time Frame

1 year

Title

Blood lipid parameters

Description

The levels of total cholesterol (TC) in mmol/L

Time Frame

1 year

Title

Blood lipid parameters

Description

The levels of triglyceride (TG) in mmol/L

Time Frame

1 year

Title

Blood lipid parameters

Description

The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L

Time Frame

1 year

Title

Blood lipid parameters

Description

The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L

Time Frame

1 year

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study.

Time Frame

Through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuming Jin, Professor

Organizational Affiliation

School of Public Health，Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dayi Hu, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Heart Center of Peking University People's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

School of Public Health, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

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