Study identification

PURI

https://redirect.ema.europa.eu/resource/35097

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

Contact details

Michael Webster-Clark

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Doctoral Fellowship
Study protocol
Initial protocol

ENCePP format protocol 9.21

English (642.31 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable