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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT02072668
Eligibility Criteria:
Inclusion Criteria:
* 18 to 65 years of age; sickle cell anemia (HbSS) or sickle-beta0 (HbSβ0) thalassemia;
* serum creatinine ≤ 1.0 mg/dL men) or 1.2 mg/dL (women);
* ALT \</= 2 times upper limits of normal;
* platelet count ≥ 50,000 cu/mm;
* normal baseline PT/international normalized ratio (INR) and aPTT;
* be in the non-crisis, "steady state" with no severe pain episodes during the preceding 4 weeks;
* ability to understand the requirements of the study and be willing to give informed consent;
* women of childbearing age must be practicing an adequate method of contraception;
* and if on hydroxyurea, be on a stable dose for at least 3 months prior to enrollment.
Exclusion Criteria:
* hypersensitivity to any component of rivaroxaban;
* history of major GI bleeding or bleeding diathesis;
* baseline Hb \< 5.5 gm/dL;
* history of clinically overt stroke;
* brain magnetic resonance imaging with angiography (MRI/MRA) scan with evidence of Moya Moya;
* pregnant or breastfeeding;
* active liver disease or ALT \> 3 times upper limit of normal;
* on chronic anticoagulant, non-steroidal anti-inflammatory (NSAID) or statin therapy;
* history of metastatic cancer;
* current alcohol abuse;
* on a chronic transfusion program or any blood transfusion in the 3 months prior to enrollment;
* ingested any investigational drugs within the past 4 weeks;
* use of CYP3A4/P-glycoprotein inducers such as carbamazepine, phenytoin, rifampin, and St John's wort;
* use of CYP3A4/P- glycoprotein inhibitors such as ketoconazole, indinavir/ritonavir, itraconazole, lopinavir/ritonavir, ritonavir, and conivaptan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02072668
Study Brief:
Protocol Section:
NCT02072668