Chronic Obstructive Pulmonary Disease (COPD) in patients who are considered to be at a higher risk of Coronary Artery Disease (CAD), myocardial infarction, and excess mortality. MedDRA version: 18.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Aspirin Tablets BP 75 mg
Product Name: Aspirin Tablets BP 75 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: acetylsalicylic acid
CAS Number: 50-78-2
Concentration unit: mg milligram(
Sponsors
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Abnormal spirometry with FEV1=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1)Any condition that is being concurrently treated through anticoagulation or antiplatelet therapy (atrial fibrillation, deep vein thrombosis, valve prosthesis, recent myocardial infarction, use of drug eluting stents) 2)Other specific contraindications to management with antiplatelet medication (bleeding risks, allergies) 3)Any contraindication for Aspirin and Ticagrelor use 4)Other concurrent terminal illnesses with life expectancy less than 1 year (congestive cardiac failure, carcinoma etc.) 5)Current involvement in another clinical trial or exposure to another IMP within the previous 30 days 6)COPD with an atypical cause (e.g. A1- antitrypsin deficiency) 7)Planned/ Expected major surgery where anti-platelet therapy would be ceased 8)Pregnancy, planned pregnancy or current breast-feeding 9)Patient is unable to provide informed consent 10)Younger than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish if treatment with blood thinning medications such as Aspirin and Ticagrelor in patients with a lung condition called chronic obstructive pulmonary disease (COPD) who are predicted to be at an increased risk of heart disease or heart attacks, will affect the function of the blood cells called platelets. This will be measured using a bedside Multiplate platelet function test.;Secondary Objective: 1)To establish if treatment with medicines that stop blood cells from sticking together and forming a blood clot (antiplatelet therapy) will lead to reduced levels of markers commonly used to detect inflammation in the body. 2)To establish if treatment with antiplatelet therapy has an effect on the stiffness of the arteries and the thickness of the inner two layers of the main blood vessels that supply the head and neck (carotid artery). 3)To capture adverse event rates (such as bleeding and worsening of breathlessness) in the chronic obstructive pulmonary disease (COPD) population.;Primary end point(s): Inhibition of Adenosine disphosphate-induced platelet aggregation from baseline to 1-month and 6-months. ;Timepoint(s) of evaluation of this end point: 1-month and 6-months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Changes in inflammatory markers including fibrinogen, hsCRP, TNF alpha, IL6, MPO from baseline to 1-month and 6-months. 2)Changes in carotid intima media thickness and non-invasive measures of vascular stiffness from baseline to 6-months. 3)Quality of life using questionnaires (EQ5D, St. George’s COPD questionnaire) at baseline and 6-months.;Timepoint(s) of evaluation of this end point: 1) Baseline, 1-month and 6-months. 2) Baseline and 6-months. 3) Baseline and 6-months. | — |
Countries
United Kingdom
Contacts
Public ContactNewcastle Clinical Trials Unit
Newcastle University
Outcome results
None listed