Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2019 |
| Start Date: | December 30, 2014 |
| End Date: | October 1, 2018 |
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study
This research study examines the safety and feasibility of aspirin with or without
Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots
- in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic
(clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as
a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role
in hemostasis, because it is predictive of thrombosis in cancer patients and because of
promising preliminary data. We expect that sP-selectin levels will be elevated in patients
before therapy with aspirin and/or statin, but that these levels will fall significantly
during treatment, rise during the observation phase, and fall during the second study period.
Patients who take part in the study have been diagnosed with a solid tumor cancer and are
considered to be intermediate to high risk for VTE. The standard of care is to give
chemotherapy for solid tumors and treat clots which develop using blood thinners.
Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots
- in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic
(clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as
a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role
in hemostasis, because it is predictive of thrombosis in cancer patients and because of
promising preliminary data. We expect that sP-selectin levels will be elevated in patients
before therapy with aspirin and/or statin, but that these levels will fall significantly
during treatment, rise during the observation phase, and fall during the second study period.
Patients who take part in the study have been diagnosed with a solid tumor cancer and are
considered to be intermediate to high risk for VTE. The standard of care is to give
chemotherapy for solid tumors and treat clots which develop using blood thinners.
Objectives
Primary: To determine efficacy of aspirin with and without simvastatin in solid tumor
patients at high- or intermediate-risk for VTE, in reducing markers of platelet activation,
levels of inflammatory and angiogenic cytokines measured using high-throughput approaches,
and clinical and investigational measures of hemostatic activation.
Secondary: To determine safety and feasibility of aspirin with or without simvastatin in
solid tumor patients at high- or intermediate-risk for VTE
Primary: To determine efficacy of aspirin with and without simvastatin in solid tumor
patients at high- or intermediate-risk for VTE, in reducing markers of platelet activation,
levels of inflammatory and angiogenic cytokines measured using high-throughput approaches,
and clinical and investigational measures of hemostatic activation.
Secondary: To determine safety and feasibility of aspirin with or without simvastatin in
solid tumor patients at high- or intermediate-risk for VTE
Inclusion Criteria:
- Histologic diagnosis of malignancy of a solid organ or lymphoma
- Planned to initiate a new systemic chemotherapy regimen (including patients starting
on first chemotherapy or patients previously treated but starting on a new regimen)
- VTE Risk Score ≥1
- Written, informed consent.
Exclusion Criteria:
- Hematologic malignancies including acute and chronic leukemias, myelodysplastic
syndromes, lymphoma and myeloma
- Primary brain tumors
- Active bleeding or high risk of bleeding in the opinion of the investigator
- Hepatic dysfunction (elevated transaminases or bilirubin > 3 times normal)
- Planned stem cell transplant
- Life expectancy < 6 months
- Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min
- Pregnancy
- Known allergy to or prior intolerance of aspirin and/or simvastatin.
- Ongoing anticoagulant, statin and/or anti-platelet therapy.
We found this trial at
1
site
Cleveland, Ohio 44195
Phone: 216-636-2690
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