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 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD) in patients who are considered to be at a higher risk of Coronary Artery Disease (CAD), myocardial infarction, and excess mortality.; MedDRA version: 18.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005475-86-GB
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-05
• Study Completion: 2017-11-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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. A1- antitrypsin deficiency)
7)Planned/ Expected major surgery where anti-platelet therapy would be ceased
8)Pregnancy, planned pregnancy or current breast-feeding
9)Patient is unable to provide informed consent
10)Younger than 18 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified