Estimating Oral Anticoagulant Comparative Effectiveness in the Setting of Effect Heterogeneity: Comparing Clinical Trial Transport and Observational Epidemiologic Methods

Study identification

• EU PAS number:
  EUPAS25659
• Study ID:
  35097
• Official title and acronym:
  Estimating Oral Anticoagulant Comparative Effectiveness in the Setting of Effect Heterogeneity: Comparing Clinical Trial Transport and Observational Epidemiologic Methods
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will estimate the effect of treating patients with atrial fibrillation with dabigatran versus warfarin on the 1- and 2-year risks of death, stroke, and major bleeding in a Medicare population using two distinct methods: 1) using traditional observational methods in claims data estimating the probability of treatment and reweighting accordingly and 2) using inverse odds of sampling weights to standardize the trial population to appear similar to the target Medicare populations with respect to baseline covariates that may modify treatment effect. These two estimates will be compared in magnitude and precision. There will also be additional analyses concerning individuals that switch to dabigatran, as well as analyses comparing weighted trial outcome to observed target population outcomes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned:05/04/2018

Actual:05/04/2018

Study start date

Planned:20/09/2018

Actual:20/09/2018

Data analysis start date

Planned:28/09/2018

Actual:01/09/2018

Date of interim report, if expected

Planned:31/12/2018

Date of final study report

Planned:30/09/2020

Sources of funding

Other

More details on funding

Doctoral Fellowship

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable