Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCO… (NCT00909298) | Clinical Trial Compass
TerminatedPhase 2
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
United States2 participantsStarted 2009-06
Plain-language 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% reduction of thrombin generation markers at 28 days compared to placebo.
Who can participate
Age range18 Years
SexALL
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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 randomizatio…
What they're measuring
1
The level of thrombin generation markers
Timeframe: 28 days following initiation of study drug