Anti-Platelets in Chronic Obstructive Pulmonary Disease

• Status: Not yet recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a 6 week crossover study in smokers with and without COPD to evaluate whether 2 weeks of dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) improves pulmonary perfusion (i.e. blood flow in the lungs measured on a contrast CT scan) compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Clopidogrel

Criteria

Inclusion Criteria - COPD Cases:

• COPD (FEV1/FVC < 0.7, FVC >= 80%), GOLD Stage I/II (FEV1 >= 50%)

• Evidence of visual emphysema (centrilobular emphysema or panlobular emphysema) on prior CT scan

• Former smoker at least 10 pack years

Inclusion Criteria - Controls:

• Normal lung function (FEV1/FVC > 0.7, FEV1 and FVC >= 80%)

• No evidence of visual emphysema on prior CT scan

• Former smoker at least 10 pack years

Exclusion Criteria:

• Platelet count < 150,000/dL or self-report of a bleeding disorder;

• Regular use of aspirin, clopidogrel or another antiplatelet medication;

• Allergy to aspirin or clopidogrel;

• History of intracranial hemorrhage, severe GI bleed or other life-threatening bleed;

• Use of blood thinner (e.g. warfarin, lovenox or novel oral anti-coagulants);

• Use of supplemental oxygen at home, other than only nocturnal use;

• Daily use of oral steroids, theophylline, roflumilast, or diuretics;

• History of major lung surgery or lung transplant;

• Chest CT scan showing significant lung mass, infiltrate (ground glass or other consolidation), or scarring/fibrosis of the lungs;

• Treatment for cancer within the last 12 months;

• Pulmonary hypertension;

• BMI > 30;

• Acute or chronic renal insufficiency (estimated glomerular filtration rate [GFR] <60 mL/min/1.73 m2 or self-report). GFR will be calculated using the CKD-EPI equation;

• Current or planned pregnancy in the next year;

• Allergy to iodine contrast;

• Use of tobacco products or E-cigarettes within 1 year;

• Exacerbation of respiratory symptoms within the previous 6 weeks, such as that requiring hospitalization, oral prednisone or antibiotics to control symptoms, or longer and not yet returned to baseline; and

• Chest, abdominal or eye surgery, or a heart attack or stroke, within the last 3 months (spirometry exclusion criteria).