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Antiplatelet Agent

dual anti-platelet therapy for Chronic Obstructive Pulmonary Disease

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary microvascular blood volume, CV

Secondary outcome measures

Diffusing capacity

Oxygen saturation

Pulmonary microvascular blood flow

+2 more

Other outcome measures

FeNO

Cognitive Therapy

Respiratory Depression

+4 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,094 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,918 Total Patients Enrolled

Carrie L Pistenmaa, MD, MSPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting volunteers at the present time?

"The clinical trial is still accepting participants, as per the most recent update posted on 12/8/2023. Initially published on December 8th of 2023, this study seeks new patients to join their ranks."

Answered by AI

How many participants is the trial allowing to enroll?

"Confirmed. Clinicaltrials.gov records show that this clinical trial is currently open for patient recruitment, having been initiated on December 8th 2023 and last updated the same day. The study requires 30 participants at a single location to form its cohort."

Answered by AI

Is this trial accessible to individuals below the age of fifty-five?

"The entrance requirements for this trial specify that the minimum age to join is 50 years and maximum age of 75, as indicated in the eligibility criteria."

Answered by AI

Is dual anti-platelet therapy associated with any potential risks for patients?

"The safety of dual anti-platelet therapy was assessed as a '2' owing to its Phase 2 status; that is, while there has been some evidence provided for safety so far, no data can yet confirm efficacy."

Answered by AI

Would I meet the criteria for participating in this clinical experiment?

"This clinical trial is looking for 30 participants, aged 50 to 75 years old, with clinically diagnosed COPD. In addition they must meet a specified set of criteria such as: having a FEV1/FVC < 0.7 and FVC >= 80%, being in GOLD Stage I or II (FEV1 >= 50%), evidence of visual emphysema on CT scan, have smoked 10 pack-years priorly, have normal lung function tests (with FEV1/FVC >0.7and both FEV1 & FVC>=80%) and no visible signs of emphysema on the previous"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-Platelets in Chronic Obstructive Pulmonary Disease

Carrie Pistenmaa, M.D 2023. "Anti-Platelets in Chronic Obstructive Pulmonary Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567562.

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