Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)

vTv Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Coagulation

Treatments

Drug: TTP889

Drug: Placebo

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00909298

TTP889-202

Details and patient eligibility

About

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% reduction of thrombin generation markers at 28 days compared to placebo.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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