Effect of Rosuvastatin Therapy on HDL2 Level
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|ClinicalTrials.gov Identifier: NCT02593487|
Recruitment Status : Unknown
Verified October 2015 by Xu-kai Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was: Not yet recruiting
First Posted : November 2, 2015
Last Update Posted : November 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipemia Coronary Heart Disease||Drug: Rosuvastatin 10mg/d group Drug: Rosuvastatin 20mg/d group||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Rosuvastatin Therapy on HDL2 Level and Antiatherosclerotic Reverse Cholesterol Transport Process in Chinses CAD Patients With Hyperlipidemia|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Rosuvastatin 10mg/d group
rosuvastatin 10mg table by mouth, qd
Drug: Rosuvastatin 10mg/d group
rosuvastatin 10mg tablet,q.d. for 12 weeks.
Other Name: Routine dose group
Active Comparator: Rosuvastatin 20mg/d group
rosuvastatin 20mg table by mouth, qd
Drug: Rosuvastatin 20mg/d group
rosuvastatin 20mg tablet,q.d. for 12 weeks.
Other Name: Loading dose group
- 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. [ Time Frame: Visit 0 (Screening and Enrollment, 0 day);Visit 1 (4weeks);Visit 2 (8weeks);Visit 3 (12weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593487
|Contact: Xu-kai Wang, PhDemail@example.com|
|Contact: Qing-kai Yan, MDfirstname.lastname@example.org|
|Xu-kai Wang||Not yet recruiting|
|Chongqing, Chongqing, China, 400042|
|Contact: Qing-kai Yan, MD +8618623457875 email@example.com|
|Contact: Peng Cai, MD +8602368757810 firstname.lastname@example.org|
|Study Chair:||Xu-kai Wang, PhD||the Department of Cardiology, Daping Hospital, the Third Military Medical University|