Antiplatelet therapy in COPD (APPLE-COPD:ICON 2)
Research type
Research Study
Full title
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease.
IRAS ID
163519
Contact name
Vijay Kunadian
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2014-005475-86
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Patients with a lung condition called Chronic Obstructive Pulmonary Disease (COPD) are known to be at an increased risk of heart disease and death due to heart attacks. This study aims to evaluate whether treatment of COPD patients with heart medications such as Aspirin and/or Ticagrelor will lead to reduced stickiness and inflammation in the blood, which may ultimately lead to reduced heart attacks and death in the future.
At present there is very little information in the literature about the best ways of treating COPD patients at risk of future heart problems. Information learned from this study may add to the medical knowledge about how to treat COPD patients who are at risk of future heart problems.
Participants will be identified at routine outpatient clinic appointments, and if eligible, allocated to either one of four treatment arms or observational arm as determined by their calculated risk of developing future cardiovascular events.
Participants in the treatment arms will be asked to attend a baseline visit; a 1 month, 3 month and 6 month follow up visits. At the baseline 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.
At 1 month the participant will undergo another routine blood test and a review of their study medication. At 3-months patients will undergo review of their medications. At 6 months the participant will undergo the same procedures performed at the baseline visit and asked to return all medication and packaging. Their general health and well-being will be recorded at 1 year.
Participants in the observational arm will undergo a blood test at the baseline visit and again at a 6 month visit. Their general health and well-being will be recorded at 1 year.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0155
Date of REC Opinion
26 May 2015
REC opinion
Further Information Favourable Opinion