Clinical trial NCT04945122: Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Glucose Metabolism Disorders
Keywords: Pitavastatin
Atorvastatin
HbA1c
LDL-C
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c reduction
timeFrame: six months after treatment
Secondary outcomes:
measure: LDL-c reduction
timeFrame: six months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: National Center for Cardiovascular Diseases, CAMS and Peking Union Medical College, Fuwai Hospital
name: Xiao-jin Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
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