Status:
TERMINATED
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
Lead Sponsor:
vTv Therapeutics
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coagulation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% re...
Eligibility Criteria
Inclusion
- Signed informed consent, release of medical information, and HIPAA forms
- Age greater than or equal to 18 years
- Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test
- Implanted with an FDA-approved LVAD (for BTT or DT indication, e.g. HeartMate® XVE) within 72 hours prior to randomization, and able to receive the first dose of study drug by 72 hours (+6 hours) post LVAD implantation
- Post-op hemostasis adequate for starting low level anticoagulation (as assessed by surgeon)
- Extubated and able to take oral medication
Exclusion
- Evidence of active bleeding within 24 hours prior to randomization
- History of a platelet disorder, including but not limited to thrombocytopenia and thrombasthenia
- Thrombocytopenia with platelets \<80,000/ml within 48 hours prior to randomization
- History of an inherited or acquired coagulation disorder
- Hemoglobin \<8 g/dL (4.85 mmol/L) or hematocrit \<26% within 24 hours prior to randomization
- Clinical indication for (or the intention to use) standard anticoagulation therapy at time of randomization (e.g., atrial fibrillation or DVT)
- Intention to treat with more than 325 mg aspirin daily
- Any clinical requirement or intention to treat with phenytoin, tolbutamide or warfarin post randomization
- RVAD support at the time of randomization
- Estimated glomerular filtration rate (GFR) ≤30 ml/min (by Cockcroft-Gault formula), or any form of dialysis within 48 hours prior to randomization
- Evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or liver enzyme values (AST or ALT) that are \>3 times the upper limit of normal; or Total Bilirubin \>1.5 times the upper limit of normal (with the exception of Gilbert's Syndrome) within 3 days prior to randomization
- Active systemic infection, in the judgment of the investigator, within 3 days prior to randomization
- Stroke or transient ischemic attack (TIA) within 6 months prior to randomization
- History of intracranial hemorrhage or gastrointestinal bleed within 3 months prior to randomization
- Alzheimer's disease, or any other form of irreversible dementia
- History of psychiatric disease (including drug or alcohol abuse) that may impair compliance with the study protocol
- Pregnant or breastfeeding at time of randomization
- Received investigational intervention within 30 days prior to randomization
- Body weight \< 45 Kg
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00909298
Start Date
June 1 2009
Last Update
June 27 2011
Active Locations (3)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029
2
New York Presbyterian Hospital / Columbia University Medical Center
New York, New York, United States, 10032
3
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99207