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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT00909298
First received: May 27, 2009
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Coagulation
Drug: TTP889
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Intrinsic Pathway Antagonists in Patients Undergoing Implantation of Left Ventricular Assist Devices

Further study details as provided by TransTech Pharma:

Primary Outcome Measures:
  • The level of thrombin generation markers [ Time Frame: 28 days following initiation of study drug ] [ Designated as safety issue: No ]
    Thrombin-antithrombin complex (TAT)and Prothrombin Fragment 1+2 (F1.2)


Secondary Outcome Measures:
  • Thrombin Generation Markers [ Time Frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]
  • Major Bleeding [ Time Frame: Day 1 to Day 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]
  • Transfusions of Blood and Blood Products [ Time Frame: Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]
  • Blood Count [ Time Frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]
  • Coagulation Markers [ Time Frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]
  • Incidence of Serious Adverse Events [ Time Frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: June 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TTP889 300 mg
Drug: TTP889
300 mg
Placebo Comparator: 2
TTP889 Placebo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909298

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
New York Presbyterian Hospital / Columbia University Medical Center
New York, New York, United States, 10032
United States, Washington
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99207
Sponsors and Collaborators
TransTech Pharma
Investigators
Principal Investigator: Alan Moskowitz, MD Mount Sinai School of Medicine
Principal Investigator: Yoshifumi Naka, MD, PhD New York Presbyterian Hospital / Columbia University Medical Center
  More Information

No publications provided

Responsible Party: Alan Moskowitz, MD Co-Director, International Center for Health Outcomes and Innovation Research
ClinicalTrials.gov Identifier: NCT00909298     History of Changes
Other Study ID Numbers: TTP889-202
Study First Received: May 27, 2009
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by TransTech Pharma:
Left ventricular assist devices
Cardiac Disease
Heart Failure
Anticoagulant for Left Ventricular Assist Devices

ClinicalTrials.gov processed this record on September 30, 2014