A Phase 2 interventional study of Ticagrelor and Aspirin in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-04.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Phase 2, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 120 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 67 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo Ticagrelor 90 mg- one tablet, twice daily. Placebo Aspirin 75 mg- one tablet, once a day.
Drug: Placebo Aspirin · Drug: Placebo Ticagrelor
Aspirin 75mg - one tablet, once a day. Placebo Ticagrelor 90 mg- one tablet, twice daily.
Drug: Aspirin · Drug: Placebo Ticagrelor
Placebo Aspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily.
Drug: Ticagrelor · Drug: Placebo Aspirin
Aspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily.
Drug: Ticagrelor · Drug: Aspirin
One 90 mg tablet, oral, twice daily for 6 months.
Also known as: Brilique
One 75 mg tablet, oral, once a day, for 6 months.
Sugar tablet to mimic Aspirin 75 mg tablet One 75 mg tablet, oral, once a day, for 6 months.
Sugar tablet to mimic Ticagrelor 90 mg tablet. Once 90 mg tablet, oral, twice daily for 6 months.
Change in baseline ASPI and ADP-induced platelet aggregation at 6 months
The primary outcome measure is platelet reactivity measured at 6-months. Response is calculated according to high platelet reactivity (HPR). Rates of HPR will be determined according to recently published definitions of HPR for multiple electrode aggregometry in patients undergoing percutaneous coronary intervention, \>46 AU for ADP test and \>40 for ASPI test. Response rate will be calculated on an intention to treat basis as the total number of patients responding as a proportion of all patients randomised and reported descriptively with 95% confidence intervals. Any patients who are not assessable at 6-months will be classed as a non-responder.
Time frame: Baseline to 6 months
Change in inflammatory markers (myeloperoxidase (MPO) measured by routine blood test at baseline, 1 month and 6 months
Measuring changes in inflammatory markers to investigate if treatment with APT is associated with reduced inflammatory marker levels (myeloperoxidase (MPO)).
Time frame: Baseline to 6 months
Change in inflammatory markers (interleukin-6 (IL-6) measured by routine blood test at baseline, 1 month and 6 months
Measuring changes in inflammatory markers to investigate if treatment with APT is associated with reduced inflammatory marker levels (interleukin-6 (IL-6)).
Time frame: Baseline to 6 months
Change in inflammatory markers (fibrinogen) measured by routine blood test at baseline, 1 month and 6 months
Measuring changes in inflammatory markers to investigate if treatment with APT is associated with reduced inflammatory marker levels (fibrinogen).
Time frame: Baseline to 6 months
Change in inflammatory markers (high sensitive C reactive protein (hsCRP) measured by routine blood test at baseline, 1 month and 6 months
Measuring changes in inflammatory markers to investigate if treatment with APT is associated with reduced inflammatory marker levels (high sensitive C reactive protein (hsCRP)).
Time frame: Baseline to 6 months
Change in inflammatory markers (tumor necrosis factor alpha (TNF) measured by routine blood test at baseline, 1 month and 6 months
Measuring changes in inflammatory markers to investigate if treatment with APT is associated with reduced inflammatory marker levels (tumor necrosis factor alpha (TNF)).
Time frame: Baseline to 6 months
Changes in carotid intima media thickness
Carotid intima media thickness measured by an ultrasound scan
Time frame: Baseline to 6 months
Changes in vascular stiffness (m/s)
Changes in vascular stiffness as measured by a cuff (Meter/Second)
Time frame: Baseline and 6-months
Quality of life using EuroQoL-5D-5L health-related quality of life instrument
The EQ-5D-5L consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system has 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent indicates his/her health state in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The EQ Visual Analogue Scale records the respondent's self-rated health on a vertical, visual analogue scale (0-100) where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). This information will be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: Baseline and 6-months
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C)
The SGRQ measures health impairment in patients with asthma and COPD. Scored 0-100 (with 0 = best outcome and 100 worst outcome)
Time frame: Baseline and 6-months
Rates of major and minor bleeding as defined by the TIMI scale
Rates of bleeding will be classified as per the TIMI Scale: Major - Intracranial haemorrhage or a ≥5 g/dl decrease in the haemoglobin concentration or a ≥15% absolute decrease in the haematocrit Minor- Observed blood loss: ≥3 g/dl decrease in the haemoglobin concentration or ≥10% decrease in the haematocrit Minor- No observed blood loss: ≥4 g/dl decrease in the haemoglobin concentration or ≥12% decrease in the haematocrit Minimal- Any clinically overt sign of haemorrhage (including imaging) that is associated with a \<3 g/dl decrease in the haemoglobin concentration or \<9% decrease in the haematocrit All Adverse Events (AE) will be reported descriptively as the number of patients experiencing an AE as a proportion of the total number of patients starting treatment.
Time frame: Baseline to 6 months
Rates of major and minor bleeding as defined by the Bleeding Academic Research Consortium (BARC) definition.
Rates of bleeding will be defined by bleeding type i.e. Type 0 -Type 5b
Time frame: Baseline to 6 months
Response on spirometry using the MRC dyspnoea scale (Breathlessness)
Spirometry will be measured using the MRC Breathlessness Scale- 1. - Not troubled by breathlessness except on strenuous exercise 2. - Short of breath when hurrying or walking up a slight hill 3. - Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace 4. - Stops for breath after about 100 m or after a few minutes on the level 5. - Too breathless to leave the house, or breathless when dressing or undressing
Time frame: Baseline to 6 months
Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) measured by spirometry
A spirometer will be used to measure Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC).
Time frame: Baseline to 6 months
The record gives a start of Sep 2015, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ticagrelor · Aspirin
Pulmonary Disease, Chronic Obstructive →
Newcastle-upon-Tyne Hospitals NHS Trust