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Completed
NCT07417631
Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
Conditions: Type 2 Diabetes
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Enrollment: 300000
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Eligibility Criteria
Eligible Cohort Entry Dates:
The study will use three data sources: Optum Clinformatics, Merative MarketScan, and Medicare.
Optum: Eligible cohort entry period between September 18, 2014 to August 31, 2025.
MarketScan: Eligible cohort entry period between October 1, 2016 to October 31, 2023.
Medicare: Eligible cohort entry period between September 18, 2014 to October 31, 2020.
FOLLOWING ELIGIBILITY OF THE REWIND TRIAL:
Inclusion Criteria:
* MI, Stroke, Revascularization procedure, Diagnosis of coronary/carotid/peripheral artery disease, diagnosis of hypertensive heart disease
* BMI \>= 23.0kg/m2
* Type 2 Diabetes Mellitus
* Chronic Kidney Disease (CKD) Stage 3/4
* Albuminuria
* Tobacco use
* Hypercholesterolemia/-lipidemia
* Stable dose of glucose-lowering drugs, use lipid-lowering drugs, use of blood pressure medication
Exclusion Criteria:
* MEN syndrome or medullary thyroid carcinoma, organ transplant, malignancy
* Severe hypoglycemic episode
* CKD stage 5 or dialysis
* Gastric emptying abnormality or bariatric surgery
* Pregnancy
* Craniocervical Instability (CCI)
* Pancreatitis
* Liver disease
* Weight loss drug
* Uncontrolled diabetes
* Acute coronary/cerebrovascular event
* Concurrent use of both study drugs
EXPANDED POPULATION:
Inclusion Criteria:
* History of MI, stroke, any surgical or percutaneous revascularization procedure, use of antihypertensive/ lipid-lowering drugs, coronary / carotid / peripheral artery disease
* BMI \>= 25.0kg/m2
* Type 2 Diabetes
Exclusion Criteria:
* Medullary thyroid carcinoma,
* MEN syndrome type 2
* Malignancy
* Type 1 diabetes or secondary diabetes
* End-stage renal disease or dialysis
* Uncontrolled diabetic retinopathy or maculopathy
* Pregnancy
* Bariatric surgery
* Prior use of pramlintide or any GLP-1-RA except dulaglutide, or any DPP4i except sitagliptin
Source: ClinicalTrials.gov (NCT07417631). StuddyBuddy aggregates publicly available trial information.