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

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04945122
Collaborator
(none)
900
Enrollment
1
Location
2
Arms
99
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
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
Actual Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pitavastatin

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

Drug: Pitavastatin
Pitavastatin 4mg Qn
Active Comparator: Atorvastatin

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

Drug: Atorvastatin
Atorvastatin 20mg Qn
Other Names:
  • Lipitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fuwai Hospital Beijing Beijing China 100037

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences, Fuwai Hospital

    Investigators

    • Principal Investigator: Xiao-jin Gao, M.D., National Center for Cardiovascular Diseases, CAMS and Peking Union Medical College, Fuwai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yuejin Yang, Vice President of Fuwai Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
    ClinicalTrials.gov Identifier:
    NCT04945122
    Other Study ID Numbers:
    • 2015-685
    First Posted:
    Jun 30, 2021
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yuejin Yang, Vice President of Fuwai Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
    Pitavastatin
    Atorvastatin
    HbA1c
    LDL-C
    Additional relevant MeSH terms:
    Myocardial Infarction
    Metabolic Diseases
    Glucose Metabolism Disorders
    Infarction
    Atorvastatin
    Pitavastatin

    Study Results

    No Results Posted as of May 12, 2022