Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
314 participants
INTERVENTIONAL
2019-03-28
2024-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Statin therapy (experimental group)
On the basis of guiding patients to control their diet and improve their lifestyle, etc.
Simvastatin 20mg/d QN Po (dosage can be adjusted according to the blood lipid level of each reexamination) Atorvastatin 10mg/d QN Po (patients who cannot tolerate the side effects of simvastatin may consider replacing this drug)
statins
On the basis of dietary intervention. Simvastatin 20mg/d QN Po (half an hour before bedtime) (dosage can be adjusted according to other indicators of blood lipid level in each review), atorvastatin 10mg/d QN Po (half an hour before bedtime) (patients who can not tolerate the side effects of simvastatin can consider replacing this drug).
Dietary intervention group (control group)
Guiding patients to control diet, improve lifestyle, etc.
Dietary intervention group (control group)
Restriction of dietary components that increase LDL-C Saturated Fatty Acids Less than 7% of total energy Dietary cholesterol \< 300 mg/d Increasing Dietary Ingredients for Reducing LDL-C Phytosterol 2\~3 g/d Water soluble dietary fiber 10\~25 g/d total energy Adjusted to maintain ideal weight or lose weight Physical activity Maintain moderate intensity exercise and consume at least 200 kcal of calories per day
Interventions
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statins
On the basis of dietary intervention. Simvastatin 20mg/d QN Po (half an hour before bedtime) (dosage can be adjusted according to other indicators of blood lipid level in each review), atorvastatin 10mg/d QN Po (half an hour before bedtime) (patients who can not tolerate the side effects of simvastatin can consider replacing this drug).
Dietary intervention group (control group)
Restriction of dietary components that increase LDL-C Saturated Fatty Acids Less than 7% of total energy Dietary cholesterol \< 300 mg/d Increasing Dietary Ingredients for Reducing LDL-C Phytosterol 2\~3 g/d Water soluble dietary fiber 10\~25 g/d total energy Adjusted to maintain ideal weight or lose weight Physical activity Maintain moderate intensity exercise and consume at least 200 kcal of calories per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female patients (35-75 years old);
3. The low-risk patients with ASCVD are detailed in Annex 1.
4. Signed written informed consent approved by IRB or IEC
Exclusion Criteria
2. Pregnancy test positive (urine or serum) in women with potential pregnancy within 7 days before administration.
3. Other invasive tumors (including the second primary breast cancer) may affect the evaluation of outcomes and the compliance of schemes, but subjects who have been cured and survived disease-free for at least five years can be selected.
4. Patients with chronic underlying liver diseases who have abnormal liver function and/or clinical manifestations:
Serum total bilirubin \> 2.5 \*ULN; or INR \> 1.5 although there was no increase in bilirubin Serum ALT or AST \> 3 \*ULN; Alkaline phosphatase \> 2.5 \*ULN; Elevated ALT or AST may gradually recover, but with progressively increased fatigue, nausea and vomiting, fever, right upper abdominal pain or tenderness.
5. Extremely high risk ASCVD patients Including acute coronary syndrome (ACS), stable coronary heart disease, revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerosis, etc.
6. High-risk ASCVD patients (in accordance with one of the following circumstances):
LDL-C\>4.9 mmol/L or TC\>7.2 mmol/L Diabetic patients with 1.8 mmol/L \< LDL-C \< 4.9 mmol/L (or) 3.1 mmol/L \< TC \< 7.2 mmol/L and age \< 40 years
The 10-year risk of ASCVD was moderate and younger than 55 years old. The remaining life risk was assessed. Those with any of the following two or more risk factors are defined as high risk:
Systolic or diastolic blood pressure (\> 160 mmHg) or (\> 100 mmHg)
* Non-HDL-C\>5.2 mmol/L (200 mg/dl)
* HDL-C \< 1.0 mmol/L (40 mg/dl)
* BMI\>28 kg/m2 Smoking
7. In the abnormal group of simple TG (triglyceride), TG (\> 5.7 mmol/L)
8. Other serious diseases, including:
Congestive heart failure (NYHA grade II, III, IV); dyspnea at rest or requiring oxygen therapy; severe infection; uncontrolled diabetes mellitus;
9. If there are serious mental or mental disorders, it is estimated that the subjects'compliance to participate in this study is not strong.
10. Drug allergies to research drugs are known.
11. Participated in other drug clinical trials in the past 30 days.
12. Failure to complete at least one cycle of clinical trials based on this protocol, and failure to evaluate safety and effectiveness.
13. Serious violation of this study program, not in accordance with the prescribed dose, method and course of treatment.
18 Years
75 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Xuefei Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
PUMCH
Locations
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PUMCH
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Filippatos TD, Liberopoulos EN, Pavlidis N, Elisaf MS, Mikhailidis DP. Effects of hormonal treatment on lipids in patients with cancer. Cancer Treat Rev. 2009 Apr;35(2):175-84. doi: 10.1016/j.ctrv.2008.09.007. Epub 2008 Nov 14.
Patnaik JL, Byers T, DiGuiseppi C, Dabelea D, Denberg TD. Cardiovascular disease competes with breast cancer as the leading cause of death for older females diagnosed with breast cancer: a retrospective cohort study. Breast Cancer Res. 2011 Jun 20;13(3):R64. doi: 10.1186/bcr2901.
Beckwitt CH, Brufsky A, Oltvai ZN, Wells A. Statin drugs to reduce breast cancer recurrence and mortality. Breast Cancer Res. 2018 Nov 20;20(1):144. doi: 10.1186/s13058-018-1066-z.
Liu B, Yi Z, Guan X, Zeng YX, Ma F. The relationship between statins and breast cancer prognosis varies by statin type and exposure time: a meta-analysis. Breast Cancer Res Treat. 2017 Jul;164(1):1-11. doi: 10.1007/s10549-017-4246-0. Epub 2017 Apr 21.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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PUMCH-SBSBC
Identifier Type: -
Identifier Source: org_study_id
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