Pharmacogenomic Drug InteractionPhase 2PREPARE-MayoNCT06322238
Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
A Phase 2 study testing PGx panel test in people with Pharmacogenomic Drug Interaction and Side Effect of Drug, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenomic Drug Interaction, Side Effect of Drug, Ineffective Drug Action
- What is being tested?
- PGx panel test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Apr 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Elisa Houwink, MD, PhD, 5073192037, houwink.elisa@mayo.edu
Mary Johnson, johnson.mary15@mayo.edu
About this study
Official title: 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)
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').
- Conditions
- Pharmacogenomic Drug Interaction, Side Effect of Drug, Ineffective Drug Action, Drug Metabolism, Poor, CYP2D6-Related, Drug Metabolism, Poor, CYP2C19-Related
- Being tested
- PGx panel test
- Keywords
- pharmacogenomics, PGx, CPIC, primary care, drug metabolism, side effects, ineffectiveness, PREPARE-Mayo
- Medical subject headings
- Drug Metabolism, Poor, CYP2D6-Related, Drug Metabolism, Poor, CYP2C19-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGx panel testDiagnostic test
In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.
| Study group | Role | What they receive |
|---|---|---|
| PGx testing arm | Experimental | Not described Receives: Diagnostic Test: PGx panel test |
| Delayed PGx testing arm | Placebo comparator | Not described Receives: Diagnostic Test: PGx panel test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reaction (ADR)
The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes
Measured: 48 weeks
Secondary outcomes (2)
PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.
The 29-item PREPARE-MAYO Clinicians' and pharmacists' Questionnaire measures the Experience and Attitude, Knowledge, Knowledge testing and Needs assessment of clinicians and pharmacists. Each item is scored from 1 (disagree) to 4 (agree). Total possible scores range from 29 to 116, with lower scores indicating less knowledge and higher scores indicating more knowledge.
Measured: 48 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire
The 10-item PROMIS Global Health measures general, physical, mental and social health. Each item is scored from 1 (poor health) to 5 (excellent health). Total possible scores range from 10 to 50, with lower scores indicating worse state of health and higher scores indicating greater state of health.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenomic Drug InteractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isa J. Houwink, Mayo Clinic
- Investigators
- Isa Houwink, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322238
- Sponsor's protocol ID
- 23-008706
- Acronym
- PREPARE-Mayo
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginniing 9 to 36 months following publication provided the investigator who proposes the use of the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data sharing use /sharing agreement with Mayo Clinic and the PI.