NCT06322238招募中2 期
A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mayo Clinic Health System-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Adverse Drug Reaction (ADR)
研究概览
简要总结
The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Subject must be ≥ 18 years old
- •Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
- •Subject is able and willing to take part and willing to be followed up on for 48 weeks
- •Subject is able to donate saliva
- •Subject has signed informed consent
- •Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email
排除标准
- •For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
- •Pregnant or lactating (to be verbally confirmed with the patient)
- •Life expectancy estimated to be less than three months as determined by patient receiving hospice care
- •Duration of index drug total treatment length is planned to be less than seven consecutive days.
- •Current inpatients
- •Unable to consent to the study
- •Unwilling to take part
- •Subject has no permanent address
- •Subject has no current primary care provider
- •Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
- •Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
- •Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
- •History of a liver transplant or an allogeneic hematopoietic stem cell transplant
- •DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory
研究组 & 干预措施
PGx testing arm
Experimental
干预措施: PGx panel test (Diagnostic Test)
Delayed PGx testing arm
Placebo Comparator
干预措施: PGx panel test (Diagnostic Test)
结局指标
主要结局
Adverse Drug Reaction (ADR)
时间窗: 48 weeks
The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire(48 weeks)
- PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.(48 weeks)
研究者
Isa J. Houwink
Principal Investigator
Mayo Clinic
研究点 (2)
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