Back to results

Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome (PCI)

Primary Purpose

Myocardial Infarction, Unstable Angina

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Atorvastatin

Statin

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial Infarction, Unstable Angina

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-85 years old
Patients with clinical diagnosis of ACS
Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
Endstage congestive heart failure, or LVEF < 30%
Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
Myopathy or increased creatine kinase (CK>2 UNL)
Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
Pregnancy, lactation, or child bearing potential women without any effective contraception
Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
Participating in other interventional clinical trails using drugs or devices
Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Sites / Locations

Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Atorvastatin

Usual care

Arm Description

80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

statin dose should not be higher than that described in exclusion criteria.

Outcomes

Primary Outcome Measures

30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI

Secondary Outcome Measures

Post-procedural change of inflammatory biomarkers (hs-CRP)

Morbidity of CIN

Elevation of ALT, AST and CK

Proportion of patients who experience at least once AST>3UNL，ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.

Number of Participants with Adverse Events

Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events

Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events

Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

serum adiponectin concentration

Full Information

NCT ID

NCT01372839

First Posted

June 10, 2011

Last Updated

June 11, 2011

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01372839

Brief Title

Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Acronym

PCI

Official Title

The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Detailed Description

This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

6. Conditions and Keywords

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

Myocardial Infarction, Unstable Angina

Keywords

Myocardial Infarction, Unstable Angina

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Active Comparator

Arm Description

80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Arm Title

Usual care

Arm Type

Other

Arm Description

statin dose should not be higher than that described in exclusion criteria.

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Intervention Type

Drug

Intervention Name(s)

Statin

Intervention Description

Usual care, but statin dose should not be higher than that described in exclusion criteria

Primary Outcome Measure Information:

Title

30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI

Time Frame

30-day

Secondary Outcome Measure Information:

Title

Post-procedural change of inflammatory biomarkers (hs-CRP)

Time Frame

24h

Title

Morbidity of CIN

Time Frame

48h

Title

Elevation of ALT, AST and CK

Description

Time Frame

6 months

Title

Number of Participants with Adverse Events

Description

Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events

Time Frame

6 months

Title

Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events

Description

Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

Time Frame

6 months

Title

serum adiponectin concentration

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-85 years old Patients with clinical diagnosis of ACS Evidence of a personally signed and dated informed consent document Exclusion Criteria: Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment. LDL-C < 1.8mmol/L in patients without statin therapy in 1 months Endstage congestive heart failure, or LVEF < 30% Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL Myopathy or increased creatine kinase (CK>2 UNL) Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L) Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases Pregnancy, lactation, or child bearing potential women without any effective contraception Accompanied with malignant disease or other disease, which cause life expectancy < 6 months Participating in other interventional clinical trails using drugs or devices Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ling Tao, M.D Ph.D

Phone

+86-15002955798

lingtao2006@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Huo, MD

Organizational Affiliation

Division of Cardiology, Peking University First Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ling Tao, M.D Ph.D

Phone

+86-15002955798

lingtao2006@gmail.com

First Name & Middle Initial & Last Name & Degree

Ling Tao, M.D Ph.D

12. IPD Sharing Statement

Learn more about this trial

Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

We'll reach out to this number within 24 hrs