Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT03487406
Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)
A Phase 2 study testing Ticagrelor and Aspirin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ticagrelor and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abnormal spirometry with FEV1<80% and FEV1/FVC ratio <70% of predicted
- Smoking history that is 10-pack years or greater (current or ex smokers can be included)
- Have capacity to consent
Who cannot join
- Any condition that is being concurrently treated through anticoagulation or antiplatelet therapy including Aspirin (any form of Aspirin) or Ticagrelor (atrial fibrillation, deep vein thrombosis, valve prosthesis, recent myocardial infarction, use of drug eluting stents)
- Other specific contraindications to management with antiplatelet medication (bleeding risks, allergies)
- Any contraindication for Aspirin and Ticagrelor use
- Other concurrent terminal illnesses with life expectancy less than 1 year (congestive cardiac failure, carcinoma etc)
- Current involvement in another clinical trial or exposure to another IMP within the previous 30 days
- COPD with an atypical cause (e.g. A1- antitrypsin deficiency)
Show all 9Show fewer
- Patients who are unable to provide informed consent
- Planned/ Expected major surgery where anti-platelet therapy would be ceased
- Pregnancy, planned pregnancy or current breast-feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
About this study
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.
Read the detailed description
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.
- Being tested
- Ticagrelor, Aspirin, Placebo Aspirin, Placebo Ticagrelor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilique
One 90 mg tablet, oral, twice daily for 6 months.
AspirinDrug
One 75 mg tablet, oral, once a day, for 6 months.
Placebo AspirinDrug
Sugar tablet to mimic Aspirin 75 mg tablet One 75 mg tablet, oral, once a day, for 6 months.
Placebo TicagrelorDrug
Sugar tablet to mimic Ticagrelor 90 mg tablet. Once 90 mg tablet, oral, twice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Ticagrelor & placebo Aspirin | Placebo comparator | Placebo Ticagrelor 90 mg- one tablet, twice daily. Placebo Aspirin 75 mg- one tablet, once a day. Receives: Drug: Placebo Aspirin; Drug: Placebo Ticagrelor |
| Aspirin & Placebo Ticagrelor | Active comparator | Aspirin 75mg - one tablet, once a day. Placebo Ticagrelor 90 mg- one tablet, twice daily. Receives: Drug: Aspirin; Drug: Placebo Ticagrelor |
| Placebo Aspirin & Ticagrelor | Active comparator | Placebo Aspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily. Receives: Drug: Ticagrelor; Drug: Placebo Aspirin |
| Aspirin & Ticagrelor | Experimental | Aspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily. Receives: Drug: Ticagrelor; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (9)
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)).
Measured: 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)).
Measured: 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).
Measured: 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)).
Measured: 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)).
Measured: Baseline to 6 months
Changes in carotid intima media thickness
Carotid intima media thickness measured by an ultrasound scan
Measured: Baseline to 6 months
Changes in vascular stiffness (m/s)
Changes in vascular stiffness as measured by a cuff (Meter/Second)
Measured: 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.
Measured: 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)
Measured: Baseline and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study startSep 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Vijay Kunadian, MBBS MD FRCP, Principal investigator, Intitute of Cellular Medicine, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487406
- Sponsor's protocol ID
- 2014-005475-86
- Other IDs
- 2014
- Status last verified
- Mar 2018
- First submitted
- 6 Oct 2015
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03487406
- Acronym / sponsor ID
- 2014-005475-86
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- AstraZeneca, Newcastle University
- Study start
- Sep 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Ticagrelor & placebo Aspirin | Placebo comparator | Drug: Placebo Aspirin, Drug: Placebo TicagrelorPlacebo Ticagrelor 90 mg- one tablet, twice daily. Placebo Aspirin 75 mg- one tablet, once a day. |
| Aspirin & Placebo Ticagrelor | Active comparator | Drug: Aspirin, Drug: Placebo TicagrelorAspirin 75mg - one tablet, once a day. Placebo Ticagrelor 90 mg- one tablet, twice daily. |
| Placebo Aspirin & Ticagrelor | Active comparator | Drug: Ticagrelor, Drug: Placebo AspirinPlacebo Aspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily. |
| Aspirin & Ticagrelor | Experimental | Drug: Ticagrelor, Drug: AspirinAspirin 75 mg - one tablet, once a day. Ticagrelor 90 mg- one tablet, twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Abnormal spirometry with FEV1<80% and FEV1/FVC ratio <70% of predicted
- Smoking history that is 10-pack years or greater (current or ex smokers can be included)
- Have capacity to consent
Key exclusion criteria (9 listed)
- Any condition that is being concurrently treated through anticoagulation or antiplatelet therapy including Aspirin (any form of Aspirin) or Ticagrelor (atrial fibrillation, deep vein thrombosis, valve prosthesis, recent myocardial infarction, use of drug eluting stents)
- Other specific contraindications to management with antiplatelet medication (bleeding risks, allergies)
- Any contraindication for Aspirin and Ticagrelor use
- Other concurrent terminal illnesses with life expectancy less than 1 year (congestive cardiac failure, carcinoma etc)
- Current involvement in another clinical trial or exposure to another IMP within the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: BriliqueOne 90 mg tablet, oral, twice daily for 6 months. | Drug | Aspirin & Ticagrelor, Placebo Aspirin & Ticagrelor |
| AspirinOne 75 mg tablet, oral, once a day, for 6 months. | Drug | Aspirin & Placebo Ticagrelor, Aspirin & Ticagrelor |
| Placebo AspirinSugar tablet to mimic Aspirin 75 mg tablet One 75 mg tablet, oral, once a day, for 6 months. | Drug | Placebo Aspirin & Ticagrelor, Placebo Ticagrelor & placebo Aspirin |
| Placebo TicagrelorSugar tablet to mimic Ticagrelor 90 mg tablet. Once 90 mg tablet, oral, twice daily for 6 months. | Drug | Aspirin & Placebo Ticagrelor, Placebo Ticagrelor & placebo Aspirin |
Primary outcome
Change in baseline ASPI and ADP-induced platelet aggregation at 6 months
Time frame: Baseline to 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.
9 secondary outcomes
Change in inflammatory markers (myeloperoxidase (MPO) measured by routine blood test at baseline, 1 month and 6 months
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
Time frame: Baseline to 6 months
Change in inflammatory markers (fibrinogen) measured by routine blood test at baseline, 1 month and 6 months
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
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
Time frame: Baseline to 6 months
Changes in carotid intima media thickness
Time frame: Baseline to 6 months
Changes in vascular stiffness (m/s)
Time frame: Baseline and 6-months
Quality of life using EuroQoL-5D-5L health-related quality of life instrument
Time frame: Baseline and 6-months
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease Patients (SGRQ-C)
Time frame: Baseline and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Kunadian, MBBS MD FRCP principal investigator
Intitute of Cellular Medicine, Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ticagrelor and Aspirin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline ASPI and ADP-induced platelet aggregation at 6 months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.