Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism

Study Overview
=================
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.

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

Conditions
-----------------
Acute Myocardial Infarction, Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Atorvastatin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin<br>Patients diagnosed AMI with abnormal glucose metabolism use pitavastatin (4mg po Qn) to control cholesterol for 6 months. | Drug: Pitavastatin<br>* Pitavastatin 4mg Qn<br>|
| Active Comparator: Atorvastatin<br>Patients diagnosed AMI with abnormal glucose metabolism use atorvastatin (20mg po Qn) to control cholesterol for 6 months. | Drug: Atorvastatin<br>* Atorvastatin 20mg Qn<br>* Other names: Lipitor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction | Comparing the impact on HbA1c of AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg | six months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-c reduction | Comparing the absolute reduction of LDL-c level in AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg | six months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atorvastatin, Pitavastatin, HbA1c, LDL-C