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New treatment option for Deep Vein Thrombosis
Official title Apixaban in Thrombocytopenia
ClinicalTrials.gov ID: NCT06886516
What this study is testing
What is Apixaban?
Apixaban is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for deep vein thrombosis.
Also referred to as 1-(4methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4c]pyridine-3-carboxamide, C25H25N5O4.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months.
- Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal...
- Platelet count \< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis.
- Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3...
- No evidence of active hemorrhage.
You likely can't join if
- Participants who are receiving any other investigational agents.
- Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent.
- Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or...
- Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant.
- Participants with luminal gastrointestinal malignancy or genitourinary cancer.
- Presence of known or prior brain metastasis, given the increased risk of life-threatening intracranial hemorrhage with anticoagulant use. While...
See the full eligibility criteria
- Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months.
- Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated...
- Platelet count \< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis.
- Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3 transfusions.
- No evidence of active hemorrhage.
- No recent history of major hemorrhage (requiring transfusion, hospitalization or intervention) within the last 12 months.
- No known brain metastases.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of apixaban in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric...
- ECOG performance status ≤2
- Participants must have adequate organ and marrow function as defined below:
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- Glomerular filtration rate (GFR) ≥25 mL/min/1.73/m2
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- The effects of apixaban on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document.
- Participants who are receiving any other investigational agents.
- Participants who have had a thrombectomy, insertion of a caval filter, or require a fibrinolytic agent.
- Participants that have index events with severe clot burden defined as bilateral proximal lower extremity deep vein thrombosis and saddle embolism or pulmonary embolism with hemodynamic compromise.
- Participants with acute myeloid leukemia or myelodysplastic syndrome or who are undergoing or have undergone allogeneic stem cell transplant.
- Participants with luminal gastrointestinal malignancy or genitourinary cancer.
- Presence of known or prior brain metastasis, given the increased risk of life-threatening intracranial hemorrhage with anticoagulant use. While screening for brain metastases is not standard of care in this population...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to apixaban.
- Participants receiving any medications or substances that are inhibitors or inducers of CYP3A/P-gp are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a...
- Participants on aspirin (\>100 mg/day), dual antiplatelet therapy, or receiving chronic treatment with NSAIDS
- Participants with uncontrolled intercurrent illness.
- Participants at high risk of bleeding such as:
- Unresected luminal/mucosal GI and GU cancers
- Active gastric or duodenal cancer
- History of major bleeding (based on ISTH criteria) in the past 12 months
- Any prior history of Intracranial hemorrhage (microhemorrhage is not included)
- Clinical or laboratory concern for ongoing DIC (prolonged PT/APTT or low fibrinogen)
- Severe renal disease (CKD Stage IV or higher) or liver disease (Child Pugh B/C)
- Participants with pre-planned major surgery within the study period
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because apixaban has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to...
- Participant must be able to swallow pills.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.