In ASCVD patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (LDL-C\>1.8mmol/L) is usually higher than that in population with normal thyroid function. The present study aims to randomly compare two lipid-lowering therapeutic strategies (statins only vs. statins combined with thyroid hormone supplement).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
248
The initial dosage of pitavastatin is 2mg, and it will be regulated according to the level of LDL-C and the upper limit is 4mg.Since the investigators are blind to the arms,the fake regulation of placebo dosage will be same as the Pitavastatin and levothyroxine group.
The initial dosage of pitavastatin is 2mg and the initial dosage of levothyroxine is 12.5ug. The dosage of levothyroxine will be regulated according to thyroid function test every 2-3 weeks. The regulation of pitavastatin dosage is same as the monotherapy group.
Fuwai Hospital, China National Center for Cardiovascular Diseases
Beijing, China
RECRUITINGChange of LDL-C levels
Absolute change value of serum LDL-C levels between the baseline and 6-month assessment.
Time frame: Baseline and 6-month.
Changes of non-LDL lipid levels (TC, TG, HDL-C, non-HDL-C)
Absolute change value of serum non-LDL lipid levels (including TC, TG, HDL-C, non-HDL-C) between the baseline and 6-month assessment.
Time frame: Baseline and 6-month
LDL-C control rate
Percentages of patients who had LDL-C values below the treatment goal (LDL-C\<1.8mmol/L) at 1-, 2-, 3- and 6-month assessment.
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Dosage of treatment drugs (pitavastatin and levothyroxine)
The dosage of pitavastatin and levothyroxine in combination group at 6-month assessment; The dosage of pitavastatin in control group at 6-month assessment
Time frame: At 6-month assessment.
Levels of thyroid hormones at 6-month assessment
Levels of thyroid hormones (thyroid-stimulating hormone, free triiodothyronine, free thyroxine, total triiodothyronine, and total thyroxine) at 6-month assessment
Time frame: At 6-month assessment.
Rates of major adverse cardiac and cerebrovascular events at 6-month assessment
Rates of major adverse cardiac and cerebrovascular events (MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events) during 6 months follow-up.
Time frame: During 6-month follow-up.
Levels of glutamic-pyruvic transaminase (ALT) at 1-, 2-, 3- and 6-month assessment
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Safety endpoint: live injury parameters, including levels of glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST).
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of glutamic-oxaloacetic transaminase (AST) at 1-, 2-, 3- and 6-month assessment
Safety endpoint: live injury parameters, including levels of glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST).
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.
Levels of serum creatine kinase (CK) at 1-, 2-, 3- and 6-month assessment
Safety endpoint: muscle injury parameter--serum creatine kinase (CK)
Time frame: Baseline and 1-, 2-, 3- and 6-month assessment.