Acute Myocardial Infarction, Glucose Metabolism Disorders
Conditions
Keywords
Pitavastatin, Atorvastatin, HbA1c, LDL-C
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.
Interventions
DRUGPitavastatin
Pitavastatin 4mg Qn
DRUGAtorvastatin
Atorvastatin 20mg Qn
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed acute myocardial infarction. 2. Diabetes or pre-diabetes. 3. The patient signed informed consent.
Exclusion criteria
1. A clear history of chronic liver disease, or abnormal liver function (ALT/AST\>1.5×ULN). 2. There is evidence of active inflammatory myopathy or CK\>3×ULN. 3. Being allergic to statins or severe side effects were caused by taking statins(including myolysis). 4. Combined with hypothyroidism, nephrotic syndrome, alcoholism, pancreatitis, lupus erythematosus. 5. All patients who had a clear adverse reaction to the statins. 6. Possibility of pregnancy, pregnant or lactating patients. 7. There may be limited medical history of subjects who may can not complete their treatment during the study period. 8. Undergoing or planning to functional renal transplantation. 9. The life expectancy is no more than half a year. 10. Patients who are taking birth control pills, steroid hormones and imidazole drugs. 11. 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. 12. Patients are not fit to be tested according to the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c reduction | six months after treatment | Comparing the impact on HbA1c of AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-c reduction | six months after treatment | Comparing the absolute reduction of LDL-c level in AMI patients with abnormal glucose metabolism using pitavastatin 4mg versus atorvastatin 20mg |
Countries
China
Contacts
Primary ContactXiao-jin Gao, M.D.
Backup ContactJingang Yang, M.D.
Outcome results
None listed