Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT01588327
Eligibility Criteria:
Inclusion Criteria:
• Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days
Exclusion Criteria:
* CrCl \< 15 ml/min
* Non-FDA approved dose based on calculated CrCl with most recent SCr
* Age \< 18 years
* Inability to communicate in the English language
* Decisionally-impaired individuals
* Incarcerated
* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT01588327
Study Brief:
Protocol Section:
NCT01588327