Type 2 Diabetes With Antiplatelet Drugs

Completed

• Conditions: Myocardial Infarction; Type2 Diabetes; Antiplatelet Drugs; Heart Failure
• Interventions: Drug: Antiplatelet Drug

• Registration Number: NCT05053828
• Lead Sponsor: Tabula Rasa HealthCare

Brief 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. 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 Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study Start: 2021-09-20
• Study First Posted: 2021-09-23
• Status Verified: 2023-01
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173464

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic patients on clopidogrel	Antiplatelet Drug	Diabetic patients on clopidogrel
Diabetic patients on antiplatelet drugs other than clopidogrel	Antiplatelet Drug	Diabetic patients on antiplatelet drugs other than clopidogrel
Non-diabetic controls on clopidogrel	Antiplatelet Drug	Non-diabetic patients prescribed clopidogrel

Primary Outcome Measures

Name	Time	Method
Measure the prevalence of clopidogrel prescription in patients with T2D in the study population.	1 year	Quantitative
Measure the prevalence of ticagrelor and prasugrel prescription in patients with T2D vs. clopidogrel.	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.	1 year	Quatitative

Trial Locations

Locations (1)

Tabula Rasa Healthcare; 🇺🇸 Orlando, Florida, United States