Effect of Rosuvastatin Therapy on HDL2 Level
1 other identifier
interventional
300
1 country
1
Brief Summary
In many large trials, reducing low density lipoprotein (LDL) levels with rosuvastatin decreased the incidence of major cardiovascular events，but little attention to the effects of rosuvastatin on HDL level，especially on HDL subtype. Epidemiological evidence strongly favors the notion that the risk of cardiovascular disease (CVD) is inversely related to the plasma high-density lipoprotein (HDL) cholesterol concentration. HDL can be subdivided into large-sized (HDL2a, HDL2b) and small-sized subclasses (preb1-HDL, HDL3c, HDL3b, HDL3a) and preb2-HDL. Some studies indicate that only large HDL2a and HDL2b particles make HDLs possess anti-atherogenic functions. The investigators assume that rosuvastatin could play the role of anti-atherosclerosis though the levels of HDL2a、HDL2b increased.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 3, 2015
October 1, 2015
1.1 years
October 29, 2015
October 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint is to detect the percentage change of HDL2 level by using rosuvastatin after 12 weeks in hyperlipidemia patients with CAD compared with baseline.
Visit 0 (Screening and Enrollment, 0 day);Visit 1 (4weeks);Visit 2 (8weeks);Visit 3 (12weeks)
Study Arms (2)
Rosuvastatin 10mg/d group
EXPERIMENTALrosuvastatin 10mg table by mouth, qd
Rosuvastatin 20mg/d group
ACTIVE COMPARATORrosuvastatin 20mg table by mouth, qd
Interventions
rosuvastatin 10mg tablet,q.d. for 12 weeks.
rosuvastatin 20mg tablet,q.d. for 12 weeks.
Eligibility Criteria
You may qualify if:
- Patients with CAD undergoing quantitative coronary angiography ;
- Patients with hyperlipidemia: TG(Triglyceride)\>1.6mmol/L and/or TC(total cholesterol)\>4.6mmol/L, and they didn't take antilipemic agents or steroid hormone at least three months before this trial.
- Patients between the ages of 30 and 75 years, the functions of liver or kidney are not severe.
You may not qualify if:
- Thyroid dysfunction, Liver or Biliary Tract Diseases, Acute Myocardial Infarction during the last half year, Renal Insufficiency or Kidney Failure and Cerebrovascular Trauma;
- Drug induce Hyperlipidemia, Familial Hypercholesterolemia;
- Having a major trauma , operation with intestines and stomach recently or the disease affecting drug absorbed;
- Having Anaphylactic Reaction, Mental Disorders and Drinking history.
- Taking statin, Nicotinic Acids and other drugs which can influence the level of HDL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xu-kai Wang
Chongqing, Chongqing Municipality, 400042, China
Related Publications (8)
Tian L, Long S, Li C, Liu Y, Chen Y, Zeng Z, Fu M. High-density lipoprotein subclass and particle size in coronary heart disease patients with or without diabetes. Lipids Health Dis. 2012 May 15;11:54. doi: 10.1186/1476-511X-11-54.
PMID: 22584085RESULTPirillo A, Norata GD, Catapano AL. High-density lipoprotein subfractions--what the clinicians need to know. Cardiology. 2013;124(2):116-25. doi: 10.1159/000346463. Epub 2013 Feb 20.
PMID: 23428644RESULTNavab M, Reddy ST, Van Lenten BJ, Anantharamaiah GM, Fogelman AM. The role of dysfunctional HDL in atherosclerosis. J Lipid Res. 2009 Apr;50 Suppl(Suppl):S145-9. doi: 10.1194/jlr.R800036-JLR200. Epub 2008 Oct 27.
PMID: 18955731RESULTBarter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, Kastelein JJ, Bittner V, Fruchart JC; Treating to New Targets Investigators. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007 Sep 27;357(13):1301-10. doi: 10.1056/NEJMoa064278.
PMID: 17898099RESULTKatabami T, Murakami M, Kobayashi S, Matsui T, Ujihara M, Takagi S, Higa M, Ichijo T, Ohta A, Tanaka Y. Efficacy of low-dose rosuvastatin in patients with type 2 diabetes and hypo high-density lipoprotein cholesterolaemia. J Int Med Res. 2014 Apr;42(2):457-67. doi: 10.1177/0300060513507648. Epub 2014 Mar 4.
PMID: 24595147RESULTKaneko K, Saito H, Takahashi T, Kiribayashi N, Omi K, Sasaki T, Niizeki T, Sugawara S, Akasaka M, Kubota I. Rosuvastatin improves plaque morphology in cerebral embolism patients with normal low-density lipoprotein and severe aortic arch plaque. J Stroke Cerebrovasc Dis. 2014 Jul;23(6):1682-9. doi: 10.1016/j.jstrokecerebrovasdis.2014.01.018. Epub 2014 Apr 13.
PMID: 24739590RESULTExpert Dyslipidemia Panel of the International Atherosclerosis Society Panel members. An International Atherosclerosis Society Position Paper: global recommendations for the management of dyslipidemia--full report. J Clin Lipidol. 2014 Jan-Feb;8(1):29-60. doi: 10.1016/j.jacl.2013.12.005. Epub 2013 Dec 17.
PMID: 24528685RESULTTian L, Li C, Liu Y, Chen Y, Fu M. The value and distribution of high-density lipoprotein subclass in patients with acute coronary syndrome. PLoS One. 2014 Jan 23;9(1):e85114. doi: 10.1371/journal.pone.0085114. eCollection 2014.
PMID: 24465490RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xu-kai Wang, PhD
the Department of Cardiology, Daping Hospital, the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD，PhD
Study Record Dates
First Submitted
October 29, 2015
First Posted
November 2, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
November 3, 2015
Record last verified: 2015-10