Platelet Activation and Reactivity in Acute Exacerbations of COPD

Overview

Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.

Full Title of Study: “Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2017

Interventions

  • Other: Blood is drawn
    • Blood analyses

Clinical Trial Outcome Measures

Primary Measures

  • Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.
    • Time Frame: Measured at presentation with an AE-COPD and after 8 weeks

Secondary Measures

  • Platelet-monocyte interaction (CD14 cells positive for CD61)
    • Time Frame: Measured at presentation with an AE-COPD and after 8 weeks
  • Monocyte activation (CD11b expression on CD14 positive cells)
    • Time Frame: Measured at presentation with an AE-COPD and after 8 weeks
  • Tissue factor triggered thrombin generation capacity
    • Time Frame: Measured at presentation with an AE-COPD and after 8 weeks
  • Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer
    • Time Frame: Measured at presentation with an AE-COPD and after 8 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • >40 years – Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < 70% and less than 12% on reversibility testing< Lower limit of normal (LLN)) – ≥10 pack years of smoking Exclusion Criteria:

  • Use of anti-coagulation or other platelet function inhibitors – Asthma – Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE) – Malignancies

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yvonne F Heijdra, Md, PhD, Principal Investigator, Radboud University Medical Center
  • Overall Contact(s)
    • Floor E Aleva, MD, 0031 24 361 03 25, floor.aleva@radboudumc.nl

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