Indication Warfarin Anticoagulation chronic
Item
1. patients with one or more of the following indications for chronic warfarin anticoagulation (the patient may either be a new candidate for anticoagulation or may already be receiving warfarin):
boolean
C3146298 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Cause Reversible Absent Electrocardiography | Atrial Flutter
Item
1. atrial fibrillation (paroxysmal, persistent or permanent, not due to a reversible cause, documented by ecg) or atrial flutter.
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0015127 (UMLS CUI [4,1])
C0205343 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1623258 (UMLS CUI [4,4])
C0004239 (UMLS CUI [5])
Heart Valve Prosthesis Position Aortic | Mitral valve prosthesis | Anticoagulation chronic Patient need for
Item
2. a prosthetic heart valve in the aortic or mitral position that requires chronic anticoagulation.
boolean
C0018825 (UMLS CUI [1,1])
C0733755 (UMLS CUI [1,2])
C0003483 (UMLS CUI [1,3])
C0182494 (UMLS CUI [2])
C0003281 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
Thromboembolism of vein | Deep Vein Thrombosis | Pulmonary Embolism | Anticoagulation Therapy Long-term Patient need for
Item
3. a history of venous thromboembolic disease (dvt and/or pe) requiring long term anticoagulation (> 6 months).
boolean
C1997614 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0003281 (UMLS CUI [4,1])
C0443252 (UMLS CUI [4,2])
C0686904 (UMLS CUI [4,3])
Myocardial Infarction | Cardiomyopathy Requirement Anticoagulation
Item
4. a history of myocardial infarction or cardiomyopathy requiring anticoagulation.
boolean
C0027051 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003281 (UMLS CUI [2,3])
Warfarin chronic
Item
5. currently receiving chronic warfarin therapy for another indication not listed, with sponsor approval.
boolean
C0043031 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Age
Item
2. male or female greater than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. able and willing to sign irb approved written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
4. able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.
boolean
C0525058 (UMLS CUI [1])
Medical contraindication Anticoagulation | Hemorrhage | Lesion Associated with Bleeding Risk | Gastric ulcer | COLON AV MALFORMATION | Arteriovenous Malformations, Cerebral | Cerebral Aneurysm | Aortic Aneurysm | Pericarditis | Endocarditis | Operative Surgical Procedures | Invasive procedure | Spinal Puncture | Hematological Disease | Blood Coagulation Disorders Hereditary | Bleeding tendency | Hemorrhagic Disorders Serious | hemorrhage; cranial | Eye Hemorrhage | Hematomyelia | Retroperitoneal hemorrhage | Gastrointestinal Hemorrhage
Item
1. contraindications to anticoagulation as listed in the warfarin package insert (appendix d), such as active bleeding or lesions at risk of bleeding such as gastric ulceration, colonic or cerebral av malformations, cerebral or aortic aneurysms, pericarditis or endocarditis. patients who have had recent (< 14 days from screening) surgery or invasive procedures or are about to undergo surgery or other invasive procedures, such as lumbar puncture. patients with blood dyscrasias or inherited disorders of hemostasis. patients with a history of hemorrhagic tendencies or prior serious hemorrhagic events such as hemorrhage within the cranium, eye, spinal cord, retroperitoneum, or gastrointestinal tract.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C3251812 (UMLS CUI [3,3])
C0038358 (UMLS CUI [4])
C0742579 (UMLS CUI [5])
C0917804 (UMLS CUI [6])
C0917996 (UMLS CUI [7])
C0003486 (UMLS CUI [8])
C0031046 (UMLS CUI [9])
C0014118 (UMLS CUI [10])
C0543467 (UMLS CUI [11])
C4048276 (UMLS CUI [12])
C0037943 (UMLS CUI [13])
C0018939 (UMLS CUI [14])
C0005779 (UMLS CUI [15,1])
C0439660 (UMLS CUI [15,2])
C1458140 (UMLS CUI [16])
C0019087 (UMLS CUI [17,1])
C0205404 (UMLS CUI [17,2])
C1390140 (UMLS CUI [18])
C0015402 (UMLS CUI [19])
C0018949 (UMLS CUI [20])
C0151705 (UMLS CUI [21])
C0017181 (UMLS CUI [22])
Hemorrhage | Positive fecal occult blood without explanation | Hematuria without explanation | Hemoglobin trace positive
Item
2. laboratory evidence at screening of clinically significant active bleeding, such as unexplained positive occult blood in stool, or unexplained positive urinary blood that is more than trace positive for hemoglobin.
boolean
C0019080 (UMLS CUI [1])
C0266813 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0681841 (UMLS CUI [2,3])
C0221752 (UMLS CUI [3,1])
C0332288 (UMLS CUI [3,2])
C0681841 (UMLS CUI [3,3])
C0019046 (UMLS CUI [4,1])
C0442822 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
Anticoagulants | Antiplatelet Agents | Involvement with Hemostatic function | clopidogrel | Ticlopidine | Heparin | Heparin, Low-Molecular-Weight | Non-Steroidal Anti-Inflammatory Agents Long-term Active | ATI 5923 Dosage | Warfarin Dosage | Aspirin Dose allowed
Item
3. concomitant use of other anticoagulant or antiplatelet agents that may add to the hemostatic burden such as clopidogrel, ticlopidine, heparin or low molecular weight heparin (lmwh), or regular use of non selective long acting nsaids that cannot be discontinued prior to initiating ati 5923/warfarin dosing (daily use of 81-100 mg aspirin is allowed).
boolean
C0003280 (UMLS CUI [1])
C0085826 (UMLS CUI [2])
C1314939 (UMLS CUI [3,1])
C0019116 (UMLS CUI [3,2])
C0070166 (UMLS CUI [4])
C0040207 (UMLS CUI [5])
C0019134 (UMLS CUI [6])
C0019139 (UMLS CUI [7])
C0003211 (UMLS CUI [8,1])
C0443252 (UMLS CUI [8,2])
C0205177 (UMLS CUI [8,3])
C2932027 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0043031 (UMLS CUI [10,1])
C0178602 (UMLS CUI [10,2])
C0004057 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0683607 (UMLS CUI [11,3])
Life Expectancy | Chronic Kidney Failure Requirement Dialysis | End-stage Lung disease Requirement Home oxygen | Heart failure Severe New York Heart Association Classification
Item
4. a life expectancy of < 1 year, end stage renal failure requiring dialysis, end stage pulmonary disease requiring home oxygen, severe heart failure (nyha class iv).
boolean
C0023671 (UMLS CUI [1])
C0022661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0011946 (UMLS CUI [2,3])
C0024115 (UMLS CUI [3,1])
C0205088 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
C0421203 (UMLS CUI [3,4])
C0018801 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
Dementia | Mental Disorders, Severe | Substance Use Disorders
Item
5. dementia, severe psychiatric disorder, or ongoing alcohol or substance abuse.
boolean
C0497327 (UMLS CUI [1])
C4046029 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Laboratory Results | Anemia, severe | Hemoglobin measurement | Thrombocytopenia | Platelet Count measurement | Liver diseases
Item
6. laboratory screening values indicating severe anemia (hb < 10 gm/l), thrombocytopenia (platelet count < 90,000/mcl), or active liver disease.
boolean
C1254595 (UMLS CUI [1])
C0238644 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0040034 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
Condition Interferes with INR Determination | Hematocrit level | Antiphospholipid Syndrome | INR abnormal
Item
7. patients with conditions that will interfere with determination of the inr using the inratio device, i.e., hematocrit <30% or >55%. patients with the antiphospholipid syndrome may have abnormal inr results and should not be enrolled.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525032 (UMLS CUI [1,3])
C1148554 (UMLS CUI [1,4])
C0518014 (UMLS CUI [2])
C0085278 (UMLS CUI [3])
C0580417 (UMLS CUI [4])
Ischemic stroke | Ischemic stroke disabling major | Intracranial Hemorrhages
Item
8. history of non disabling ischemic stroke within the last 3 months, prior major disabling ischemic stroke, or any history of intracranial bleeding.
boolean
C0948008 (UMLS CUI [1])
C0948008 (UMLS CUI [2,1])
C0596452 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0151699 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Contraceptives, Oral | implantable contraceptive capsules | Intrauterine Devices | Contraception, Barrier | Female Condoms | Vaginal Spermicides
Item
9. pregnant or nursing women or women of childbearing potential who will not use adequate contraception, such as oral or implantable contraceptives, iud, or barrier methods (iud or condom) with spermicide.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C2048401 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
Study Subject Participation Status | Investigational New Drugs
Item
10. currently participating in another clinical trial at screening, treatment with an investigational drug within 30 days of the first dose of study medication, or patients who previously participated in an ati-5923 trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])