Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients With Chronic Obstructive Pulmonary Disease
Patients with COPD (chronic bronchitis and/or emphysema) are known to be at an increased risk
of heart disease and death due to heart attacks. There are several possible reasons for this,
one of which is an increased tendency of the blood to clot, that can give rise to blood clot
formation in the coronary arteries, and lead to heart attack. Medications such as Aspirin and
another new blood thinning tablet called Ticagrelor are already used for patients with heart
attacks. Given that patients with COPD are at higher risk of heart attack, the investigators
wish to see if these tablets that can prevent blood clot formation in heart arteries might
also prevent heart attacks happening in COPD patients. The investigators hope to understand
the effects by measuring clotting and inflammation in the blood. All patients will be
followed up for 6-months.
In addition the investigators wish to study COPD patients who do not have a high risk of
developing future heart problems using the QRISK score to study their well being over a 1
year period to see if they might also benefit from blood thinning medications.
The APPLE-COPD: ICON2 trial is a double blinded, proof-of-concept, randomised controlled
trial that will include patients who have not been previously targeted in clinical
cardiovascular research. The study will consist of patients with a lung condition called
chronic obstructive pulmonary disease (COPD) who have not previously been diagnosed with
coronary artery disease (CAD) and yet are at higher risk of CAD, myocardial infarction, and
excess mortality (as determined by QRISK2 score). The QRISK2 is a simple questionnaire for
heart disease that uses well known risk factors such as age, high blood pressure, smoking
status and abnormal cholesterol levels. A QRISK score over 20 (20% risk of a cardiovascular
event over the next ten years) is already used as a prompt to consider cholesterol lowering
therapy (such as statins).
Patients with COPD (chronic bronchitis and/or emphysema) are known to be at an increased risk
of heart disease and death due to heart attacks. There are several possible reasons for this,
one of which is an increased tendency of the blood to clot which can give rise to blood clot
formation in the coronary arteries, and lead to heart attack. Medications such as Aspirin and
another new blood thinning tablet called Ticagrelor are already used for patients with heart
attacks. Given that patients with COPD are at higher risk of heart attack, the investigators
wish to see if these tablets that can prevent blood clot formation in heart arteries, might
also prevent heart attacks happening in COPD patients. The investigators hope to understand
the effects by measuring clotting and inflammation in the blood.
Aspirin and Ticagrelor are widely used in the UK for the management of coronary artery
disease. For purposes of this study, Aspirin and Ticagrelor will be treated as an
Investigational Medicinal Product (IMP). As a 2x2 factorial design, the primary analyses are
based on a comparison of i) Aspirin vs no Aspirin and ii) Ticagrelor vs. no Ticagrelor
(resulting in 4 treatment arms). Treatment allocation will be blinded to both the
investigator and the participant.
Participants allocated to the treatment arms will be requested to take their trial medication
for 6 months and will then be followed up clinically for a further 6 months by the research
team to monitor any adverse events and the participant's well-being.
Participants allocated to the observational arm will be followed up for 1 year.
At 1 year all trial procedures will end and the patient will continue to receive routine care
by the clinical care team.
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