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Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

19 Participants Needed

Antiplatelet Therapy for COPD

Overseen ByMaria A Cinelli

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Antiplatelets, Blood thinners, NSAIDs, Steroids

Disqualifiers: Bleeding disorders, Obesity, Cancer, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as aspirin, clopidogrel, other antiplatelet medications, blood thinners, NSAIDs, oral steroids, and some other specific drugs. If you are on any of these, you may need to stop them to participate.

What data supports the effectiveness of the drug Dual Antiplatelet Therapy (DAPT) for COPD?

While there is no direct evidence for DAPT's effectiveness in COPD, DAPT, which includes aspirin and a P2Y12 inhibitor like clopidogrel, is effective in reducing heart-related events in conditions like acute coronary syndrome and during procedures like percutaneous coronary intervention. This suggests potential benefits in managing blood clot risks, although its specific impact on COPD is not established.¹ ² ³ ⁴ ⁵

Is antiplatelet therapy generally safe for humans?

Antiplatelet therapy, including dual antiplatelet therapy (DAPT) with aspirin and clopidogrel, is commonly used and generally safe for preventing blood clots in heart disease and stroke patients, but it can increase the risk of bleeding.¹ ³ ⁴ ⁶ ⁷

How is the drug DAPT unique for treating COPD?

DAPT, which combines aspirin and a P2Y12 inhibitor like clopidogrel, is unique for COPD as it is primarily used to prevent blood clots in heart conditions, not typically for lung diseases. This trial explores its novel use in COPD, potentially offering a new approach by targeting blood clotting mechanisms that might play a role in COPD complications.¹ ⁴ ⁶ ⁸ ⁹

Research Team

Carrie Pistenmaa, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

Your previous CT scan shows signs of visual emphysema in your lungs.

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

Your previous CT scan doesn't show signs of visual emphysema.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dual antiplatelet therapy (aspirin 81mg and clopidogrel 75mg) for 2 weeks, followed by a 2-week washout period, and then 2 weeks of placebo, or vice versa

6 weeks

2 visits (in-person) for CT scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Dual Anti-Platelet Therapy
Placebo

Trial OverviewThe 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.

Participant Groups

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

Dual Anti-Platelet Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as DAPT for:

Prevention of thrombotic events after percutaneous coronary intervention (PCI) with drug-eluting stents (DES)
Acute coronary syndrome (ACS)
Chronic coronary syndrome

Approved in United States as DAPT for:

Prevention of thrombotic events after PCI with DES
ACS
Secondary prevention of cardiovascular events

Approved in Canada as DAPT for:

Prevention of thrombotic events after PCI with DES
ACS
Chronic coronary syndrome

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Dual antiplatelet therapy (DAPT) using clopidogrel and aspirin is recommended for preventing recurrent ischemic events in patients with coronary heart disease and stroke, highlighting its efficacy in reducing complications.

However, clopidogrel has limitations, such as variable patient response and delayed recovery of platelet function, which may necessitate the exploration of newer antiplatelet agents like prasugrel, ticagrelor, and PAR-1 inhibitors for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antiplatelet drugs].Nishikawa, M.[2018]

Dual anti-platelet therapy, specifically the combination of aspirin and clopidogrel, significantly reduces the risk of recurrent heart attacks and death in patients with acute coronary syndromes, as shown in multiple randomized control trials.

Despite the benefits of this combination, many patients still face ischemic events due to the limitations of aspirin and clopidogrel, prompting the development of new anti-platelet agents that are currently being evaluated in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Platelet Therapy for Acute Coronary Syndrome: A Review of Currently Available Agents and What the Future Holds.Syed, FA., Bett, JH., Walters, DL.[2019]

The SMART-CHOICE trial is a large-scale study involving 3000 patients that aims to determine if P2Y12 inhibitor monotherapy can effectively reduce thrombotic events while lowering the risk of bleeding compared to dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor after 3 months of treatment.

The primary outcome will assess the safety and efficacy of the treatment strategies by measuring all-cause death, myocardial infarction, and cerebrovascular events over 12 months, providing valuable insights into the optimal antiplatelet therapy following percutaneous coronary intervention with drug-eluting stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the comparison between a P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients undergoing implantation of coronary drug-eluting stents (SMART-CHOICE): A prospective multicenter randomized trial.Song, YB., Oh, SK., Oh, JH., et al.[2019]