Type 2 Diabetes With Antiplatelet Drugs

January 20, 2023 updated by: Tabula Rasa HealthCare

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Tabula Rasa HealthCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

PACE population is adults aged 55 years and older who are eligible for Medicare and Medicaid.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients not taking above mentioned anti-platelet medications during the period in which data is collected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-diabetic controls on clopidogrel
Non-diabetic patients prescribed clopidogrel
Drug: Antiplatelet Drug
Antiplatelet drugs and agents
Other Names:
  • Clopidogrel
Diabetic patients on clopidogrel
Drug: Antiplatelet Drug
Antiplatelet drugs and agents
Other Names:
  • Clopidogrel
Diabetic patients on antiplatelet drugs other than clopidogrel
Drug: Antiplatelet Drug
Antiplatelet drugs and agents
Other Names:
  • Clopidogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.
Time Frame: 1 year
Quantitative
1 year
Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.
Time Frame: 1 year
Quantitative
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.
Time Frame: 1 year
Quatitative
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabula Rasa HealthCare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRHC-T2D-2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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