EUCTR2014-005475-86-GB
Active, not recruiting
Phase 1
Anti-platelet Therapy in the Primary Prevention of Cardiovascular Disease in Patients with Chronic Obstructive Pulmonary Disease. - Antiplatelet therapy in COPD (APPLE-COPD:ICON 2)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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