NL-OMON46828已完成不适用
Moderate Alcohol and Cardiovascular Health Trial - MACH15
Julius Clinical0 个研究点目标入组 500 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age *50 years at screening
- •2. Postmenopausal, defined as 12 consecutive months without menstruation
- •3. Not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years
- •4. High risk for the occurrence of a (new) cardiovascular disease event, definition see protocol chapter 4.2.
排除标准
- •1. High alcohol consumption, definition see protocol chapter 4.3.
- •2. Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of *6 on questions 7, 8, and 10
- •3. Within the 6 months prior to randomization, cardiovascular disease event (MI, revascularization procedure, or stroke)
- •4. AHA Class III-IV heart failure
- •5. History of alcohol or substance abuse (medical record confirmed or self-reported history)
- •6. Other intolerance or allergy to alcohol
- •7. Dual antiplatelet therapy
- •8. History of gastric bypass surgery
- •9. Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transpeptidase [GGT]) >2 times the upper limit of the normal range using local standards
- •10. Personal history of any colon or liver cancer
- •11. Any other cancer with a life expectancy of less than 3 years
- •12. Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
- •13. Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
- •14. Estimated glomerular filtration rate (eGFR) <30 ml/min /1.73m2 or end-stage renal disease (ESRD)
- •15. Ongoing use of any medication for which alcohol consumption is contraindicated
- •16. A Patient Health Questionnaire (PHQ-9) *15 at screening
- •17. History of any organ transplant
- •18. Unintentional weight loss >10% in last 6 months
- •19. Currently participating in another clinical trial (intervention trial)
- •20. Not willing or able to provide a name and contact information for at least one additional contact person other than self
- •21. Diagnosis of dementia.
- •22. Investigator discretion regarding appropriateness of participation or concern about intervention adherence, examples include: moderate * severe psychiatric illness, behavioral concerns regarding likelihood of low adherence to trial protocol, a medical condition likely to limit survival to less than 3 years, or an advanced chronic disease, such as cognitive impairment without a dementia diagnosis dementia, or any condition that requires 24-hour care.
- •23. Not willing or able to provide a signed and dated informed consent form
- •24. Unable to successfully complete the washout period
- •25. Not willing or able to comply with all trial procedures
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