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Antiplatelet Agent

Antiplatelet Therapy for COPD

Phase 2

Recruiting

Led By Carrie L Pistenmaa, MD, MS

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Former smoker at least 10 pack years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial studies how dual antiplatelet therapy affects lung blood flow in people who have quit smoking, some with COPD.

Who is the study for?

This trial is for former smokers, with or without Chronic Obstructive Pulmonary Disease (COPD), who have a history of significant smoking. Participants must show signs of emphysema on a CT scan and meet specific lung function criteria (FEV1/FVC < 0.7 and FVC >= 80%). Those with normal lung function but no visual emphysema are also eligible.

What is being tested?

The study is testing if dual anti-platelet therapy (aspirin and clopidogrel) over two weeks can improve blood flow in the lungs compared to a placebo. This six-week crossover study involves participants switching between the treatment and placebo.

What are the potential side effects?

Potential side effects from dual anti-platelet therapy may include increased risk of bleeding, bruising easily, upset stomach, heartburn, diarrhea, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild to moderate COPD with specific lung function levels.

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I have smoked the equivalent of 10 packs of cigarettes a year.

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My lung function is normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pulmonary microvascular blood volume, CV

Secondary study objectives

Oxygen saturation

Pulmonary microvascular blood volume

Other study objectives

FeNO

Cognitive Therapy

Respiratory Depression

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: COPD Cases: Dual antiplatelet therapy first, then placeboExperimental Treatment2 Interventions

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

Group II: Controls: Dual antiplatelet therapy first, then placeboActive Control2 Interventions

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

Group III: COPD Cases: Placebo first, then dual antiplatelet therapyPlacebo Group2 Interventions

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

Group IV: Controls: Placebo first, then dual antiplatelet therapyPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670