CoagulationPhase 2NCT00909298
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
A Phase 2 study testing TTP889 in people with Coagulation, run by vTv Therapeutics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation
- What is being tested?
- TTP889
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai School of Medicine
New York, New York, 10029
New York Presbyterian Hospital / Columbia University Medical Center
New York, New York, 10032
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99207
About this study
Official title: A Randomized Clinical Trial of Intrinsic Pathway Antagonists in Patients Undergoing Implantation of Left Ventricular Assist Devices
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.
- Conditions
- Coagulation
- Being tested
- TTP889, Placebo
- Keywords
- Left ventricular assist devices, Cardiac Disease, Heart Failure, Anticoagulant for Left Ventricular Assist Devices
- Medical subject headings
- Thrombosis, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTP889Drug
300 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TTP889 300 mg Receives: Drug: TTP889 |
| 2 | Placebo comparator | TTP889 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of thrombin generation markers
Thrombin-antithrombin complex (TAT)and Prothrombin Fragment 1+2 (F1.2)
Measured: 28 days following initiation of study drug
Secondary outcomes (6)
Thrombin Generation Markers
Measured: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Major Bleeding
Measured: Day 1 to Day 42 (± 4) days post-randomization
Transfusions of Blood and Blood Products
Measured: Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Blood Count
Measured: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Coagulation Markers
Measured: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Incidence of Serious Adverse Events
Measured: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Alan Moskowitz, MD, Principal investigator, Icahn School of Medicine at Mount SinaiYoshifumi Naka, MD, PhD, Principal investigator, New York Presbyterian Hospital / Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909298
- Sponsor's protocol ID
- TTP889-202
- Status last verified
- Jun 2011
- First submitted
- 27 May 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Intrinsic Pathway Antagonists in Patients Undergoing Implantation of Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT00909298
- Acronym / sponsor ID
- TTP889-202
- Conditions
- Coagulation
- Keywords
- Left ventricular assist devices, Cardiac Disease, Heart Failure, Anticoagulant for Left Ventricular Assist Devices
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 28 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TTP889TTP889 300 mg |
| 2 | Placebo comparator | Drug: PlaceboTTP889 Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTP889300 mg | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
The level of thrombin generation markers
Time frame: 28 days following initiation of study drug
Thrombin-antithrombin complex (TAT)and Prothrombin Fragment 1+2 (F1.2)
6 secondary outcomes
Thrombin Generation Markers
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Major Bleeding
Time frame: Day 1 to Day 42 (± 4) days post-randomization
Transfusions of Blood and Blood Products
Time frame: Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Blood Count
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Coagulation Markers
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Incidence of Serious Adverse Events
Time frame: Baseline, Days 1, 3, 5, 7, 14, 21, 28 (±2); and 42 (± 4) days post-randomization
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Moskowitz, MD principal investigator
Icahn School of Medicine at Mount Sinai
Yoshifumi Naka, MD, PhD principal investigator
New York Presbyterian Hospital / Columbia University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTP889 in people with Coagulation, run by vTv Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of thrombin generation markers (time frame: 28 days following initiation of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.