Type2 DiabetesNCT05053828
Type 2 Diabetes With Antiplatelet Drugs
An observational study of Type2 Diabetes and Antiplatelet Drugs, run by Tabula Rasa HealthCare at 1 site in United States.
Trial summary
Tabula Rasa HealthCare (TRHC), d/b/a CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes, Antiplatelet Drugs, Myocardial Infarction
- What is being tested?
- Antiplatelet Drug
- How many people
- 173,464 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: PACE population is adults aged 55 years and older who are eligible for Medicare and Medicaid.
Who may be able to join
- Patient is enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period; or patient's data enrolled with health plan organization having partnership with TRHC; or patient's data from the IBM Watson database.
- Patient must be taking anti-platelet medication including clopidogrel, prasugrel, and ticagrelor during the period in which data is collected.
Who cannot join
- Patients not taking above mentioned anti-platelet medications during the period in which data is collected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Type 2 Diabetes on Outcomes Associated With Antiplatelet Drugs: A Retrospective Analysis
Tabula Rasa HealthCare (TRHC), d/b/a CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes. Pharmacist-led clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Through mutual data-sharing agreements, patient data will be collected retrospectively for patients satisfying the inclusion and exclusion criteria.
TRHC via other programs such as the Center for Medicare \& Medicaid Enhanced Medication Therapy Management program with BlueCross BlueShield Northern Plain Alliance and ClearStone, or via collaboration as third party with other health plans can have access to de-identified patient's data. TRHC has also established an agreement with the Watson IBM database to retrieve relevant patients' information for research.
Read the detailed description
This research is a retrospective observational study which does not involve interaction neither intervention with any subjects or their treatment. Using deidentified data, we plan to collect information about every subject including but not limited to demographic information (age, gender, race), drug claims, health outcomes and disease outcomes (using ICD10 codes), and cost. Data will be collected from the time patient enrolled in PACE in partnership with TRHC or from other health care plans working in collaboration with TRHC. Subjects prescribed antiplatelet agents will be identified. ICD10 codes will be used to determine disease conditions (type 2 diabetes, type 1 diabetes, non-diabetic). Next, patients prescribed clopidogrel will be identified from patients prescribed alternate anti-platelet therapy (excluding aspirin). For each cohort, Major Adverse Cardiac Event (MACE) outcomes, hospitalization data relating to bleeding incidents, stent thrombosis, mortality due to cardiovascular events, and all-cause mortality outcomes will be extracted from ICD10 codes and health insurance data. Using the medication list, the medication risk score (MRS®) and cost data will be extracted and analyses will be conducted to address our study objectives.
- Being tested
- Antiplatelet Drug
- Medical subject headings
- Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet DrugDrug
Also called Clopidogrel
Antiplatelet drugs and agents
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic controls on clopidogrel | Non-diabetic patients prescribed clopidogrel Receives: Drug: Antiplatelet Drug | |
| Diabetic patients on clopidogrel | Diabetic patients on clopidogrel Receives: Drug: Antiplatelet Drug | |
| Diabetic patients on antiplatelet drugs other than clopidogrel | Diabetic patients on antiplatelet drugs other than clopidogrel Receives: Drug: Antiplatelet Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.
Quantitative
Measured: 1 year
Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.
Quantitative
Measured: 1 year
Calculate MedWise Risk Score (TM) of <10, 11-14, 15-19, 20-30, >30 for T2D patients to examine patient risk for adverse drug events.
Quatitative
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start20 Sep 2021
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabula Rasa HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronique Michaud, Principal investigator, Tabula Rasa HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053828
- Sponsor's protocol ID
- TRHC-T2D-2021-001
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Type 2 Diabetes on Outcomes Associated With Antiplatelet Drugs: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05053828
- Acronym / sponsor ID
- TRHC-T2D-2021-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173,464 participants (actual)
- Lead sponsor
- Tabula Rasa HealthCareIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tabula Rasa HealthCare (TRHC), d/b/a CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 140 PACE sites, across the country. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes. Pharmacist-led clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Through mutual data-sharing agreements, patient data will be collected retrospectively for patients satisfying the inclusion and exclusion criteria.
TRHC via other programs such as the Center for Medicare \& Medicaid Enhanced Medication Therapy Management program with BlueCross BlueShield Northern Plain Alliance and ClearStone, or via collaboration as third party with other health plans can have access to de-identified patient's data. TRHC has also established an agreement with the Watson IBM database to retrieve relevant patients' information for research.
Detailed description
This research is a retrospective observational study which does not involve interaction neither intervention with any subjects or their treatment. Using deidentified data, we plan to collect information about every subject including but not limited to demographic information (age, gender, race), drug claims, health outcomes and disease outcomes (using ICD10 codes), and cost. Data will be collected from the time patient enrolled in PACE in partnership with TRHC or from other health care plans working in collaboration with TRHC. Subjects prescribed antiplatelet agents will be identified. ICD10 codes will be used to determine disease conditions (type 2 diabetes, type 1 diabetes, non-diabetic). Next, patients prescribed clopidogrel will be identified from patients prescribed alternate anti-platelet therapy (excluding aspirin). For each cohort, Major Adverse Cardiac Event (MACE) outcomes, hospitalization data relating to bleeding incidents, stent thrombosis, mortality due to cardiovascular events, and all-cause mortality outcomes will be extracted from ICD10 codes and health insurance data. Using the medication list, the medication risk score (MRS®) and cost data will be extracted and analyses will be conducted to address our study objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic controls on clopidogrel | – | Drug: Antiplatelet DrugNon-diabetic patients prescribed clopidogrel |
| Diabetic patients on clopidogrel | – | Drug: Antiplatelet DrugDiabetic patients on clopidogrel |
| Diabetic patients on antiplatelet drugs other than clopidogrel | – | Drug: Antiplatelet DrugDiabetic patients on antiplatelet drugs other than clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PACE population is adults aged 55 years and older who are eligible for Medicare and Medicaid.
Key inclusion criteria (2 listed)
- Patient is enrolled in a healthcare organization where TRHC provides pharmacy services during the implementation period; or patient's data enrolled with health plan organization having partnership with TRHC; or patient's data from the IBM Watson database.
- Patient must be taking anti-platelet medication including clopidogrel, prasugrel, and ticagrelor during the period in which data is collected.
Key exclusion criteria (1 listed)
- Patients not taking above mentioned anti-platelet medications during the period in which data is collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiplatelet DrugAlso: ClopidogrelAntiplatelet drugs and agents | Drug | Diabetic patients on antiplatelet drugs other than clopidogrel, Diabetic patients on clopidogrel, Non-diabetic controls on clopidogrel |
Primary outcome
Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.
Time frame: 1 year
Quantitative
Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.
Time frame: 1 year
Quantitative
Calculate MedWise Risk Score (TM) of <10, 11-14, 15-19, 20-30, >30 for T2D patients to examine patient risk for adverse drug events.
Time frame: 1 year
Quatitative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Michaud principal investigator
Tabula Rasa HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Antiplatelet Drugs, run by Tabula Rasa HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the prevalence of clopidogrel prescription in patients with T2D in the study population. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.