Status:
COMPLETED
Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2)
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsors:
AstraZeneca
Newcastle University
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03487406
Start Date
September 1 2015
End Date
November 1 2017
Last Update
April 4 2018
Active Locations (1)
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1
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN