Status:
COMPLETED
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Solid Tumor
Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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, lun...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02285738
Start Date
December 30 2014
End Date
October 1 2018
Last Update
May 8 2019
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195