Anti-Platelets in Chronic Obstructive Pulmonary Disease | NCT05567562

NCT05567562

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
K23HL141651	U.S. NIH Grant/Contract		View source

Status Module

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

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
dual anti-platelet therapy	Combination Product	dual anti-platelet therapy	COPD Cases: Dual antiplatelet therapy first, then placebo COPD Cases: Placebo first, then dual antiplatelet therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	After 2 weeks of therapy

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary Microvascular Blood Volume	Pulmonary microvascular blood volume on dual energy CT scan, comparing on dual antiplatelet therapy to placebo	After 2 weeks of therapy
Oxygen Saturation

Other Outcomes

Measure	Description	Time Frame
Small Vessel Fraction on CT	Small vessel volume (vessels <5mm2 in CSA) as a percent of total lung volume, measured on non-contrast inspiratory CT	After 2 weeks of therapy
Percent Emphysema on CT	Percent of lung below -950HU on non-contrast inspiratory CT

Eligibility Module

Eligibility Criteria

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 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 (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;
Treatment for cancer (systemic therapy or surgical/radiation within the thorax) in the 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] <60 mL/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 that requiring hospitalization, oral prednisone or antibiotics to control symptoms, or longer and not yet returned to baseline; and
Chest, abdominal or eye surgery, or a heart attack or stroke, within the last 3 months.

Name	Affiliation	Role
Carrie L Pistenmaa, MD, MS	Brigham and Women's Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

Arm/Group Information

ID	Title	Description
FG000	COPD Cases: On Dual Antiplatelet Therapy First	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
FG001	COPD Cases: On Placebo First	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
FG002	Controls: On Dual Antiplatelet Therapy First	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
FG003	Controls: On Placebo First	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	COPD Cases: Dual Anti-platelet Therapy First, Then Placebo	Dual anti-platelet therapy (aspirin 81mg and clopidogrel 75mg) will be given for 2 weeks, followed by 2 weeks without intervention, then 2 weeks of placebo
BG001	COPD Cases: Placebo First, Then Dual Anti-platelet Therapy

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

This is a crossover study and each participant received each treatment. The analyses presented are 1) All subjects comparing the outcome measures on and off treatment (N=14), 2) COPD subjects comparing the outcome measures on and off treatment (N=10), and 3) Control subjects comparing the outcome measures on and off treatment (N=4).

Posted

Mean

Standard Deviation

After 2 weeks of therapy

ID	Title	Description
OG000	On Dual Anti-platelet Therapy	On dual anti-platelet therapy, all subjects together
OG001	On Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	COPD on Dual Anti-platelet Therapy	COPD subjects on aspirin and clopidogrel	0

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bruising	Blood and lymphatic system disorders		Systematic Assessment	mild bruising on skin

More Info Module

Certain Agreements

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D000080903	Dual Anti-Platelet Therapy
D001241	Aspirin
D000077144	Clopidogrel

ID	Term
D004359	Drug Therapy, Combination
D004358	Drug Therapy
D013812	Therapeutics
D012459	Salicylates

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema