Back to resultsComparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism (CAPE-AMI)
Primary Purpose
Acute Myocardial Infarction, Glucose Metabolism Disorders
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Pitavastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Pitavastatin, Atorvastatin, HbA1c, LDL-C
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed acute myocardial infarction.
- Diabetes or pre-diabetes.
- The patient signed informed consent.
Exclusion Criteria:
- A clear history of chronic liver disease, or abnormal liver function (ALT/AST>1.5×ULN).
- There is evidence of active inflammatory myopathy or CK>3×ULN.
- Being allergic to statins or severe side effects were caused by taking statins(including myolysis).
- Combined with hypothyroidism, nephrotic syndrome, alcoholism, pancreatitis, lupus erythematosus.
- All patients who had a clear adverse reaction to the statins.
- Possibility of pregnancy, pregnant or lactating patients.
- There may be limited medical history of subjects who may can not complete their treatment during the study period.
- Undergoing or planning to functional renal transplantation.
- The life expectancy is no more than half a year.
- Patients who are taking birth control pills, steroid hormones and imidazole drugs.
- Patients who have participated in clinical trials of other drugs within 1 month, or known that clinical follow-up or research on drug compliance poorly.
- Patients are not fit to be tested according to the researchers.
Sites / Locations
- Fuwai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pitavastatin
Atorvastatin
Arm Description
Patients diagnosed AMI with abnormal glucose metabolism use pitavastatin (4mg po Qn) to control cholesterol for 6 months.
Patients diagnosed AMI with abnormal glucose metabolism use atorvastatin (20mg po Qn) to control cholesterol for 6 months.
Outcomes
Primary Outcome Measures
HbA1c reduction
Comparing the impact on HbA1c of AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg
Secondary Outcome Measures
LDL-c reduction
Comparing the absolute reduction of LDL-c level in AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg
Full Information
NCT ID
NCT04945122
First Posted
January 23, 2018
Last Updated
May 7, 2022
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04945122
Brief Title
Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism
Acronym
CAPE-AMI
Official Title
Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in Acute Myocardial Infarction (AMI) Patients With Abnormal Glucose Metabolism: a Multicenter Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Different types of statins show different influences on glycometabolism. There are no systemic analyses of the effects that statins exert on the metabolism of glucoses so far in China. This research aims to compare impacts on the glycometabolism of pitavastatin in AMI patients with atorvastatin and to accumulate data for guiding the utilization of statins.
Detailed Description
General study design:
This study is a prospective, multicenter, open and randomized controlled clinical trial, which utilize online registration database of CAMI to do the enrollment, randomization and follow-up. We will select 14 of the centers to compete into the group. The researchers used a central randomized distribution system to prescribe medication for patients. Follow the method of drug administration approved by the state drug administration department, we will estimate the efficacy and safety of treatment at the following timing: baseline, one month and six months after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Glucose Metabolism Disorders
Keywords
Pitavastatin, Atorvastatin, HbA1c, LDL-C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin
Arm Type
Experimental
Arm Description
Patients diagnosed AMI with abnormal glucose metabolism use pitavastatin (4mg po Qn) to control cholesterol for 6 months.
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Patients diagnosed AMI with abnormal glucose metabolism use atorvastatin (20mg po Qn) to control cholesterol for 6 months.
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin 4mg Qn
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin 20mg Qn
Primary Outcome Measure Information:
Title
HbA1c reduction
Description
Comparing the impact on HbA1c of AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg
Time Frame
six months after treatment
Secondary Outcome Measure Information:
Title
LDL-c reduction
Description
Comparing the absolute reduction of LDL-c level in AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg
Time Frame
six months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed acute myocardial infarction.
Diabetes or pre-diabetes.
The patient signed informed consent.
Exclusion Criteria:
A clear history of chronic liver disease, or abnormal liver function (ALT/AST>1.5×ULN).
There is evidence of active inflammatory myopathy or CK>3×ULN.
Being allergic to statins or severe side effects were caused by taking statins(including myolysis).
Combined with hypothyroidism, nephrotic syndrome, alcoholism, pancreatitis, lupus erythematosus.
All patients who had a clear adverse reaction to the statins.
Possibility of pregnancy, pregnant or lactating patients.
There may be limited medical history of subjects who may can not complete their treatment during the study period.
Undergoing or planning to functional renal transplantation.
The life expectancy is no more than half a year.
Patients who are taking birth control pills, steroid hormones and imidazole drugs.
Patients who have participated in clinical trials of other drugs within 1 month, or known that clinical follow-up or research on drug compliance poorly.
Patients are not fit to be tested according to the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-jin Gao, M.D.
Phone
+8613810644383
Email
sophie_gao@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingang Yang, M.D.
Phone
+8613810821420
Email
jingangyang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-jin Gao, M.D.
Organizational Affiliation
National Center for Cardiovascular Diseases, CAMS and Peking Union Medical College, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-jin Gao, M.D.
Phone
+8613810644383
Email
sophie_gao@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism
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