Treatment with medications that prevent the formation of blood clots, in the primary prevention of heart disease in patients with a stable lung condition called Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

• Conditions: Topic: Cardiovascular disease, Respiratory disorders; Subtopic: Cardiovascular (all Subtopics), Respiratory (all Subtopics); Disease: Cardiovascular, Respiratory; Respiratory; Chronic obstructive pulmonary disease

• Registration Number: ISRCTN43245574
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29804061 protocol (added 17/05/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31403053/ (added 08/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-21
• Study Completion: 2017-11-10
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Aged 18 years or over
2. Abnormal spirometry with FEV1<80% and FEV1/FVC ratio <70% of predicted
3. Smoking history that is 10 years or greater (current or ex smokers can be included)
4. Patient has the capacity to consent

Exclusion Criteria

1. Any condition that is being concurrently treated through anticoagulation or antiplatelet therapy (atrial fibrillation, deep vein thrombosis, valve prosthesis, recent myocardial infarction, use of drug eluting stents)
2. Other specific contraindications to management with antiplatelet medication (bleeding risks, allergies)
3. Any contraindication for Aspirin and Ticagrelor use
4. Other concurrent terminal illnesses with life expectancy less than 1 year (congestive cardiac failure, carcinoma etc.)
5. Current involvement in another clinical trial or exposure to another IMP within the previous 30 days
6. COPD with an atypical cause (e.g. A1antitrypsin deficiency)
7. Planned/ Expected major surgery where anti-platelet therapy would be ceased
8. Pregnancy, planned pregnancy or current breastfeeding
9. Patient is unable to provide informed consent
10. Younger than 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inhibition of adenosine disphosphate-induced platelet aggregation measured using the multiplate test at baseline and 6 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in inflammatory markers including fibrinogen, hsCRP, TNF alpha, IL-6, MPO is measured from blood samples taken at baseline and 6 months<br> 2. Changes in carotid intima media thickness measured using an ultrasound probe and vascular stiffness measured using a specialised pressure cuff similar to a blood pressure cuff at baseline and 6 months<br> 3. Quality of life measured using questionnaires (EQ5D-5L, St. George’s COPD questionnaire) at baseline and 6 months<br>