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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

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

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

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.

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.

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.

participants will be observed for thrombotic evens for 4 weeks

Observation

Alok A Khorana, MD

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.

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

Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis

Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study

Change in sP-selectin levels as indicator of measure efficacy

The safety endpoint will be bleeding complications over 17 weeks (16 weeks of study plus an additional week of observation). This will include major bleeding events and clinically significant non-major bleeding events. A bleeding event will be defined as major if it satisfies one or more of the following: decrease in hemoglobin of 2 g/dL or more, leads to transfusion of two or more units of blood or packed cells, occurs in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leads to death. Clinically significant, non-major bleeding will be defined as bleeding that does not meet the criteria for major bleeding, and has at least one of the following characteristics: multiple-source bleeding; spontaneous hematoma \>25 cm2; epistaxis \>5 min; macroscopic hematuria not related to instrumentation; spontaneous rectal bleeding; gingival bleeding \> 5 min; hemoptysis; hematemesis; or prolonged bleeding (\> 5 min) after venipuncture.

measure of efficacy using plasma level of platelet activation markers

measure of efficacy using plasma level of angiogenesis markers

measure of efficacy using plasma level of hemostatic activation markers

the number of thrombotic events measured by the number of events related to venus thrombosis, pulmonary embolism, visceral vein thrombosis as well as arterial thromboembolic events including stroke, myocardial infarction or arterial embolism

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis	NCT02285738	Solid Tumor Cancer	Aspirin Simvastatin Observation	18 Years -	Case Comprehensive Cancer Center
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis	NCT02285738	Solid Tumor Cancer	Aspirin Simvastatin Observation	18 Years -	Case Comprehensive Cancer Center
Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis	NCT02285738	Solid Tumor Cancer	Aspirin Simvastatin Observation	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for solid tumor, cancer, simvastatin, aspirin, blood clot, vte, venous thromboembolism