NCT07417631Completed
Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300000 (actual)
- First submitted
- 11 Feb 2026
- Start date
- 3 Feb 2026
- Primary completion date
- 15 Jun 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07417631
What you commit to
- Study type: Observational
- Participants enrolled: 300000
- From 3 Feb 2026 to the primary completion date, 15 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastric emptying abnormality or bariatric surgery
- Weight loss drug
- Concurrent use of both study drugs
- EXPANDED POPULATION:
- Bariatric surgery
- Prior use of pramlintide or any GLP-1-RA except dulaglutide, or any DPP4i except sitagliptin
Other illness
- MEN syndrome or medullary thyroid carcinoma, organ transplant, malignancy
- Liver disease
- Uncontrolled diabetes
- MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- End-stage renal disease or dialysis
Other
- Severe hypoglycemic episode
- CKD stage 5 or dialysis
- Pregnancy
- Craniocervical Instability (CCI)
- Pancreatitis
- Acute coronary/cerebrovascular event
- Medullary thyroid carcinoma,
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- 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:
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.