Anti-Platelets in Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Emphysema; COPD; Emphysema or COPD
• Interventions: Combination Product: dual anti-platelet therapy; Drug: Placebo

• Registration Number: NCT05567562
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This is a 6 week crossover study in current and former 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.

Detailed Description

This is a single-center Phase IIa randomized double-blind crossover study in smokers with and without chronic obstructive pulmonary disease (COPD) to test whether dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) improves pulmonary perfusion (i.e. blood flow in the lungs) compared to placebo.

We will enroll 30 subjects (20 with COPD, 10 without) who will each take part for 6 weeks. Participants and researchers will be blinded, they will not know which medications they are on first. Each participant will be asked to take aspirin and clopidogrel together for 2 weeks and also matching placebos for 2 weeks, with a 2 week washout period in between. Pulmonary blood flow will be evaluated with a contrast-enhanced CT scan of the chest two times over the 6 week study.

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-05
• Study Start: 2024-03-27
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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, clopidogrel, albuterol or iodine/IV contrast;
• BMI > 35;
• 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);
• Continuous use of supplemental oxygen at home;
• Regular use of an NSAID;
• Daily use of oral steroids, theophylline, roflumilast, or loop diuretics;
• History of organ transplant or autoimmune disease on systemic therapy (rheumatoid arthritis, lupus);
• Use of a biologic medication with regular injections;
• Other current lung disease (interstitial lung disease, idiopathic pulmonary fibrosis, asthma);
• IV drug use within the last year;
• History of lung surgery to remove part of the lung;
• Known bullae or advanced destructive emphysema in more than 1/3 of the lungs;
• Treatment for cancer (systemic therapy or surgical/radiation within the thorax) in the last 12 months;
• Known diagnosis of pulmonary hypertension;
• Known systolic heart failure (RV or LV EF < 40%);
• 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;
• Regular marijuana smoking;
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COPD Cases: Dual antiplatelet therapy first, then placebo	Placebo	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
Controls: Dual antiplatelet therapy first, then placebo	Placebo	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
Controls: Placebo first, then dual antiplatelet therapy	Placebo	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
Controls: Placebo first, then dual antiplatelet therapy	dual anti-platelet therapy	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
COPD Cases: Placebo first, then dual antiplatelet therapy	Placebo	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy
Controls: Dual antiplatelet therapy first, then placebo	dual anti-platelet therapy	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
COPD Cases: Dual antiplatelet therapy first, then placebo	dual anti-platelet therapy	Dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
COPD Cases: Placebo first, then dual antiplatelet therapy	dual anti-platelet therapy	Placebos for each therapy (2 pills) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of dual antiplatelet therapy

Primary Outcome Measures

Name	Time	Method
Pulmonary microvascular blood volume, CV	6 weeks	Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo

Secondary Outcome Measures

Name	Time	Method
Pulmonary microvascular blood volume	6 weeks	Pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo
Oxygen saturation	6 weeks	Resting oxygen saturation

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States