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:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01318057
Eligibility Criteria:
Inclusion Criteria:
* Patients whose parents are both Puerto Ricans; male and female aged \> 18 years old
* Scheduled to receive the standard 5 mg/day oral dose of warfarin for therapeutic anti-coagulation in indications such as deep vein thrombosis (DVT) with or without Pulmonary Embolism (PE)
* Atrial fibrillation (AF) or other arrhythmias, cardiac valvular replacement, and previously diagnosed coagulopathy
* Hematocrit (Hct) \> 40%
* Blood Urea Nitrogen (BUN)/creatinine \< 30/1.5 mg/dL
* Patients having the ability to understand the requirements of the study and to comply with study procedures and protocol
* Female patient is eligible to enter the study if she is of child-bearing potential but not pregnant or nursing, or not of child-bearing potential
Exclusion Criteria:
* Patients currently enrolled in another active research protocol at the Veteran Affairs Caribbean Healthcare System (VACHS) Hospital
* Blood Urea Nitrogen (BUN)/creatinine \> 30/2.0 mg/dL
* Active hepatic disease (defined by a Child-Pugh score above 10 points)
* Ascites
* Total bilirubin above 2.0 mg/dl
* Serum albumin below 3.5 g/dl
* Prothrombin time in seconds prolonged over control \> 4
* Hepatic encephalopathy
* Prolonged diarrhea (three or more days)
* Nasogastric or enteral feedings
* Acute illness (e.g., sepsis, infection, anemia)
* Lymphocyte function test (LFT)\> 3x upper limit of normal (ULN)
* Active malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01318057
Study Brief:
Protocol Section:
NCT01318057