Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in average sP-selectin levels
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Aspirin+Asprin/Simvastatin+Observation (ASO)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day with daily dose of Simvastatin with a 2-week washout period, ending with 4 weeks of observation
干预措施: Aspirin (Drug)
Aspirin+Asprin/Simvastatin+Observation (ASO)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day with daily dose of Simvastatin with a 2-week washout period, ending with 4 weeks of observation
干预措施: Simvastatin (Drug)
Aspirin+Asprin/Simvastatin+Observation (ASO)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day with daily dose of Simvastatin with a 2-week washout period, ending with 4 weeks of observation
干预措施: Observation (Other)
Aspirin+Observation+Asprin/Simvastatin (AOS)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day with daily dose of Simvastatin
干预措施: Aspirin (Drug)
Aspirin+Observation+Asprin/Simvastatin (AOS)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day with daily dose of Simvastatin
干预措施: Simvastatin (Drug)
Aspirin+Observation+Asprin/Simvastatin (AOS)
Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day with daily dose of Simvastatin
干预措施: Observation (Other)
Aspirin/Simvastatin+Observation+Asprin (SOA)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day
干预措施: Aspirin (Drug)
Aspirin/Simvastatin+Observation+Asprin (SOA)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day
干预措施: Simvastatin (Drug)
Aspirin/Simvastatin+Observation+Asprin (SOA)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day
干预措施: Observation (Other)
Aspirin/Simvastatin+Asprin+Observation (SAO)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day and a 2-week washout, ending with observation for 4 weeks.
干预措施: Aspirin (Drug)
Aspirin/Simvastatin+Asprin+Observation (SAO)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day and a 2-week washout, ending with observation for 4 weeks.
干预措施: Simvastatin (Drug)
Aspirin/Simvastatin+Asprin+Observation (SAO)
Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day and a 2-week washout, ending with observation for 4 weeks.
干预措施: Observation (Other)
Observation+Aspirin/Simvastatin+Asprin (OSA)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks.
干预措施: Aspirin (Drug)
Observation+Aspirin/Simvastatin+Asprin (OSA)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks.
干预措施: Simvastatin (Drug)
Observation+Aspirin/Simvastatin+Asprin (OSA)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks.
干预措施: Observation (Other)
Observation+Aspirin+Asprin/Simvastatin (OAS)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin.
干预措施: Aspirin (Drug)
Observation+Aspirin+Asprin/Simvastatin (OAS)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin.
干预措施: Simvastatin (Drug)
Observation+Aspirin+Asprin/Simvastatin (OAS)
Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin.
干预措施: Observation (Other)
结局指标
主要结局
Change in average sP-selectin levels
时间窗: at 16 weeks of treatment
Change in sP-selectin levels as indicator of measure efficacy
次要结局
- Change in average serum thromboxane B2(at 16 weeks of treatment)
- Change in average serum hepatocyte growth factor(at 16 weeks of treatment)
- Change in average plasma TAT complexes(at 16 weeks of treatment)
- Change in average serum PDGF(at 16 weeks of treatment)
- Change in the number of thrombotic events(17 weeks after beginning treatment)
- Change in average serum VEGF(at 16 weeks of treatment)
- Frequency of major bleeding complications or clinically significant non-bleeding complications per patient(at 17 weeks after beginning treatment)
- Change in average Platelet Factor 4(at 16 weeks of treatment)
- Change in average CD40 ligand(at 16 weeks of treatment)
- Change in average serum angiopoietin-2(at 16 weeks of treatment)
- Change in average serum PECAM(at 16 weeks of treatment)
- Change in average plasma F1.2(at 16 weeks of treatment)
- Change in average plasma D-dimer(at 16 weeks of treatment)