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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
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Xu-kai Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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. [ Time Frame: Visit 0 (Screening and Enrollment, 0 day);Visit 1 (4weeks);Visit 2 (8weeks);Visit 3 (12weeks) ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with CAD undergoing quantitative coronary angiography ;
  2. 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.
  3. Patients between the ages of 30 and 75 years, the functions of liver or kidney are not severe.

Exclusion Criteria:

  1. Thyroid dysfunction, Liver or Biliary Tract Diseases, Acute Myocardial Infarction during the last half year, Renal Insufficiency or Kidney Failure and Cerebrovascular Trauma;
  2. Drug induce Hyperlipidemia, Familial Hypercholesterolemia;
  3. Having a major trauma , operation with intestines and stomach recently or the disease affecting drug absorbed;
  4. Having Anaphylactic Reaction, Mental Disorders and Drinking history.
  5. Taking statin, Nicotinic Acids and other drugs which can influence the level of HDL.

Information from the National Library of Medicine

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


Contacts
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Contact: Xu-kai Wang, PhD +8602368757811 wangxuk@163.com
Contact: Qing-kai Yan, MD +8618623457875 yanqingkai@hotmail.com

Locations
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China, Chongqing
Xu-kai Wang Not yet recruiting
Chongqing, Chongqing, China, 400042
Contact: Qing-kai Yan, MD    +8618623457875    yanqingkai@hotmail.com   
Contact: Peng Cai, MD    +8602368757810    doubleboy1987@sina.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
AstraZeneca
Investigators
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Study Chair: Xu-kai Wang, PhD the Department of Cardiology, Daping Hospital, the Third Military Medical University

Publications of Results:

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Responsible Party: Xu-kai Wang, MD,PhD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02593487     History of Changes
Other Study ID Numbers: ESR-14-10333
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Xu-kai Wang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Coronary Artery Disease
Hyperlipidemia
Rosuvastatin
Lipoproteins
high-density lipoprotein
HDL2
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hyperlipidemias
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors