Extrait

Background and study aims Chronic obstructive pulmonary disease (COPD) is the collective name for a group of diseases which affect the lungs. People who suffer from COPD have difficulty breathing, which gets worse over time. This is because the airways become narrowed or blocked, and the air sacs (alveoli) in the lungs are destroyed or lose their ability to stretch. The main cause of COPD is smoking, which over time permanently damages the lining of the lungs. Many studies have shown that people with COPD have a greater risk of developing heart and blood vessel disease (cardiovascular disease) which can lead to a heart attack. When a person is suffering from cardiovascular disease (CVD), fatty substances (plaque) build up inside blood vessels causing them to become narrowed. Platelets (a component of blood) “stick” to the walls of these narrowed blood vessels, causing blockages (occlusion) that can lead to a heart attack. Ticagrelor is a medication which works by slowing and stopping platelets from sticking to the blood vessel walls. It is usually taken with aspirin, which makes this more effective by “thinning” the blood. These medications are often used in CVD patients and have been shown to be very effective. Currently there is very little information about the best way to treat COPD patients who are at risk of heart disease. The aim of this study is to find out whether treatment with ticagrelor and/or aspirin can help to lower the risk of heart disease in COPD patients. Who can participate? Adults who have smoked for at least 10 years with signs of COPD. What does the study involve? Participants are randomly allocated to one of three treatment groups or a control group. Those in the treatment groups are given aspirin and/or ticagrelor to take, and those in the control group are given a placebo (dummy pill). At the initial visit, participants will undergo a blood test, a lung function test, an ultrasound scan, they will have their stiffness of the blood vessels measured and they will be asked to complete questionnaires. Participants who are receiving the treatment attend follow up visits at 1, 3 and 6 months to see whether the medication is having any effect. The blood tests and questionnaires are repeated at a 6 month follow up visit for both groups. What are the possible benefits and risks of participating? There are no direct benefits to the patient for participating in this study. However, their participation in this study may add to the medical knowledge about how to treat COPD patients who are at risk of future heart problems. There are minor risks related to taking the study medications (asprin and ticagrelor), however the benefits have been judged to outweigh the risks. Where is the study run from? Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? September 2015 to May 2017 Who is funding the study? AstraZeneca UK Limited (UK) Who is the main contact? Mrs Andrea Bell

Critère d'inclusion

• Topic: Cardiovascular disease, Respiratory disorders; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Cardiovascular, Respiratory

Liens

• ictrp
• isrctn