Platelet Activation and Reactivity in Acute Exacerbations of COPD

COPD Exacerbation Clinical Trial

Official title:

Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03017625
• Other study ID #: 2016-2847
• Status: Not yet recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: January 9, 2017
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: Radboud University
• Contact: Floor E Aleva, MD
• Phone: 0031 24 361 03 25
• Email: floor.aleva[@]radboudumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Other:
• Blood is drawn
Blood analyses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.		Measured at presentation with an AE-COPD and after 8 weeks	No
Secondary	Platelet-monocyte interaction (CD14 cells positive for CD61)		Measured at presentation with an AE-COPD and after 8 weeks	No
Secondary	Monocyte activation (CD11b expression on CD14 positive cells)		Measured at presentation with an AE-COPD and after 8 weeks	No
Secondary	Tissue factor triggered thrombin generation capacity		Measured at presentation with an AE-COPD and after 8 weeks	No
Secondary	Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer		Measured at presentation with an AE-COPD and after 8 weeks	No