The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

Completed

Conditions studied: Atrial Fibrillation

In brief

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Key facts

Study ID

NCT02043808

Run by

Boehringer Ingelheim

People needed

25586

Starts

2014-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be continuously enrolled in a health plan during the pre-index period;
• Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
• Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
• Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
• Aged 18-89 on the index date;

You may not qualify if…

• Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
• Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

Where it is running

• 1160.183.01 Boehringer Ingelheim Investigational Site — Lexington, Massachusetts, United States

Full record on ClinicalTrials.gov

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