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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 4

Conditions: Glucose Metabolism Disorders; Acute Myocardial Infarction

Treatments: Drug: Pitavastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04945122

2015-685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Pitavastatin

Experimental group

Description:

Patients diagnosed AMI with abnormal glucose metabolism use pitavastatin (4mg po Qn) to control cholesterol for 6 months.

Treatment:

Drug: Pitavastatin

Atorvastatin

Active Comparator group

Description:

Patients diagnosed AMI with abnormal glucose metabolism use atorvastatin (20mg po Qn) to control cholesterol for 6 months.

Treatment:

Drug: Atorvastatin