Anti-Platelets in Chronic Obstructive Pulmonary Disease

NCT05567562 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 2022P002327K23HL141651
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Emphysema; Emphysema or COPD

Keywords

Platelet Dysfunction; Pulmonary Blood Vessel Injury; COPD; Emphysema

Outcome Measures

Primary Outcomes (1)

• Pulmonary microvascular blood volume, CV

  Coefficient of variation (CV) of pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo

  6 weeks

Secondary Outcomes (2)

• Pulmonary microvascular blood volume

  6 weeks

• Oxygen saturation

  6 weeks

Other Outcomes (6)

• Vascular pruning on CT

  6 weeks

• Percent emphysema on CT

  6 weeks

• Functional small airways disease on CT

  6 weeks

Study Arms (4)

COPD Cases: Dual antiplatelet therapy first, then placebo

EXPERIMENTAL

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

Combination Product: dual anti-platelet therapy; Drug: Placebo

COPD Cases: Placebo first, then dual antiplatelet therapy

PLACEBO COMPARATOR

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

Combination Product: dual anti-platelet therapy; Drug: Placebo

Controls: Dual antiplatelet therapy first, then placebo

ACTIVE COMPARATOR

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

Combination Product: dual anti-platelet therapy; Drug: Placebo

Controls: Placebo first, then dual antiplatelet therapy

PLACEBO COMPARATOR

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

Combination Product: dual anti-platelet therapy; Drug: Placebo

Interventions

dual anti-platelet therapy COMBINATION_PRODUCT

dual anti-platelet therapy

Also known as: aspirin 81mg EC tab, clopidogrel 75mg tab

COPD Cases: Dual antiplatelet therapy first, then placebo; COPD Cases: Placebo first, then dual antiplatelet therapy; Controls: Dual antiplatelet therapy first, then placebo; Controls: Placebo first, then dual antiplatelet therapy

Placebo DRUG

Placebo

COPD Cases: Dual antiplatelet therapy first, then placebo; COPD Cases: Placebo first, then dual antiplatelet therapy; Controls: Dual antiplatelet therapy first, then placebo; Controls: Placebo first, then dual antiplatelet therapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD (FEV1/FVC \< 0.7, FVC \>= LLN), GOLD Stage I/II/III (FEV1 \>= 40%)
• Current or former smoker of at least 10 pack years
• Normal lung function (FEV1/FVC \>= 0.7, FEV1 and FVC \>= LLN)
• Current or former smoker of at least 10 pack years

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

Dual Anti-Platelet Therapy; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Carrie L Pistenmaa, MD, MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, investigators and care providers will be blinded as to dual-anti platelet therapy or placebo treatment
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double-blind crossover study is a Phase 2 interventional study to assess whether dual-anti platelet therapy improves pulmonary blood flow compared to placebo

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: March 27, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)