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Completed

NCT Number: NCT02285738

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

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.

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Key information

Conditions

Solid Tumor Cancer Cardiovascular Diseases Embolism and Thrombosis Neoplasms Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

81mg/day for 4 weeks

simvastatin

Drug

Daily dose of Simvastatin for 4 weeks

observation

Other

participants will be observed for thrombotic evens for 4 weeks

Primary outcomes

  1. Change in average sP-selectin levels

    Time frame: at 16 weeks of treatment

    Change in sP-selectin levels as indicator of measure efficacy

Secondary outcomes

  1. Frequency of major bleeding complications or clinically significant non-bleeding complications per patient

    Time frame: at 17 weeks after beginning treatment

    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.

  2. Change in average Platelet Factor 4

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of platelet activation markers

  3. Change in average CD40 ligand

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of platelet activation markers

  4. Change in average serum thromboxane B2

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of platelet activation markers

  5. Change in average serum VEGF

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of angiogenesis markers

  6. Change in average serum angiopoietin-2

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of angiogenesis markers

  7. Change in average serum hepatocyte growth factor

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of angiogenesis markers

  8. Change in average serum PECAM

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of angiogenesis markers

  9. Change in average serum PDGF

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of angiogenesis markers

  10. Change in average plasma F1.2

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of hemostatic activation markers

  11. Change in average plasma TAT complexes

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of hemostatic activation markers

  12. Change in average plasma D-dimer

    Time frame: at 16 weeks of treatment

    measure of efficacy using plasma level of hemostatic activation markers

  13. Change in the number of thrombotic events

    Time frame: 17 weeks after beginning treatment

    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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 7, 2014
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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