Anti-Platelets in Chronic Obstructive Pulmonary Disease

Last updated: April 16, 2025
Sponsor: Brigham and Women's Hospital
Overall Status: Completed

Phase

2

Condition

Emphysema

Treatment

Placebo

dual anti-platelet therapy

Clinical Study ID

NCT05567562
2022P002327
K23HL141651
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria - COPD Cases:

  • COPD (FEV1/FVC < 0.7, FVC >= LLN), GOLD Stage I/II/III (FEV1 >= 40%)

  • Current or former smoker of at least 10 pack years

Inclusion Criteria - Controls:

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

  • Current or former smoker of at least 10 pack years

Exclusion

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 (rheumatoidarthritis, lupus);

  • Use of a biologic medication with regular injections;

  • Other current lung disease (interstitial lung disease, idiopathic pulmonaryfibrosis, 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) inthe 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] <60mL/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 thatrequiring hospitalization, oral prednisone or antibiotics to control symptoms, orlonger and not yet returned to baseline; and

  • Chest, abdominal or eye surgery, or a heart attack or stroke, within the last 3months.

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 27, 2024
Estimated Completion Date:
February 28, 2025

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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