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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Xuanwu Hospital, Beijing |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pivastatin and placebo | Placebo Comparator | After randomization, patients in Pivastatin + placebo group will receive pitavastatin and placebo. |
|
| Pivastatin and LT-4 | Experimental | After randomization, patients in combination group will receive pitavastatin as the lipid-lowering therapy and take levothyroxine as the thyroid hormone supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin and placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of LDL-C levels | Absolute change value of serum LDL-C levels between the baseline and 6-month assessment. | Baseline and 6-month. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6-month |
| LDL-C control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunli Shao, MD | Contact | 0086-10-88396171 | chunlishao@126.com | |
| Wenyao Wang, MD, PhD | Contact | 0086-10-88396173 | wwypumc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi-Da Tang, MD | Fuwai Hospital, China National Center for Cardiovascular Diseases | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, China National Center for Cardiovascular Diseases | Recruiting | Beijing | 100031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20615126 | Background | Gjedde S, Gormsen LC, Rungby J, Nielsen S, Jorgensen JO, Pedersen SB, Riis AL, Weeke J, Moller N. Decreased lipid intermediate levels and lipid oxidation rates despite normal lipolysis in patients with hypothyroidism. Thyroid. 2010 Aug;20(8):843-9. doi: 10.1089/thy.2009.0212. | |
| 11041458 | Background | Tzotzas T, Krassas GE, Konstantinidis T, Bougoulia M. Changes in lipoprotein(a) levels in overt and subclinical hypothyroidism before and during treatment. Thyroid. 2000 Sep;10(9):803-8. doi: 10.1089/thy.2000.10.803. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| OTHER |
| Beijing Friendship Hospital | OTHER |
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|
| Pitavastatin and levothyroxine | Drug | 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. |
|
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.
| 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 | 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 | 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. | During 6-month follow-up. |
| Levels of glutamic-pyruvic transaminase (ALT) 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). | 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). | 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) | Baseline and 1-, 2-, 3- and 6-month assessment. |
| 7852521 | Background | Pazos F, Alvarez JJ, Rubies-Prat J, Varela C, Lasuncion MA. Long-term thyroid replacement therapy and levels of lipoprotein(a) and other lipoproteins. J Clin Endocrinol Metab. 1995 Feb;80(2):562-6. doi: 10.1210/jcem.80.2.7852521. |
| 18073305 | Background | Pearce EN, Wilson PW, Yang Q, Vasan RS, Braverman LE. Thyroid function and lipid subparticle sizes in patients with short-term hypothyroidism and a population-based cohort. J Clin Endocrinol Metab. 2008 Mar;93(3):888-94. doi: 10.1210/jc.2007-1987. Epub 2007 Dec 11. |
| 18996793 | Background | Lando HM, Burman KD. Two cases of statin-induced myopathy caused by induced hypothyroidism. Endocr Pract. 2008 Sep;14(6):726-31. doi: 10.4158/EP.14.6.726. |
| 24217672 | Background | Willard DL, Leung AM, Pearce EN. Thyroid function testing in patients with newly diagnosed hyperlipidemia. JAMA Intern Med. 2014 Feb 1;174(2):287-9. doi: 10.1001/jamainternmed.2013.12188. No abstract available. |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |