Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coagulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

TTP889 300 mg

Group Type EXPERIMENTAL

TTP889

Intervention Type DRUG

300 mg

2

TTP889 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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TTP889

300 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No