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Aspirin Resistance in OSA Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930875
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Accriva Diagnostics
Information provided by (Responsible Party):
Jose Luis Mendez, Danbury Hospital

Brief Summary:
Obstructive Sleep Apnea (OSA) patients are at increased risk of major cardiovascular events, so many patients take aspirin for prevention. Poor responsiveness to aspirin is a major clinical concern because it can potentially worsen the prognosis of OSA patients. However, continuous positive airway pressure (CPAP) therapy that is considered standard of care for OSA treatment may potentially lead to improvement in responsiveness to aspirin. This study will determine whether CPAP therapy decreases patients' aspirin resistance in OSA patients with a new diagnosis or existing moderate to severe OSA who are treated with CPAP and take aspirin for prevention.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Other: Aspirin Resistance testing

Detailed Description:

Obstructive Sleep Apnea (OSA) is a common sleep-related breathing disorder that afflicts more than 25 million adults in the United States. This number continues to rise yearly due to increased incidence of obesity in the United States. The prevalence of OSA among males and females is also on the rise with 34% of males and 17% of females diagnosed with this disease.

OSA is characterized as intermittent pharyngeal soft-tissue obstruction due to anatomical or positional etiology during sleep. This leads to episodes of hypoxemia and apneas which result in overall sleep fragmentation. The pathophysiology associated with OSA is complex. However, some proposed causes of OSA include hypoxia during sleep which causes increased circulating catecholamines and sympathetic activation, free radical formation leading to oxidative stress, increased cytokine release and endothelial dysfunction. These proposed mechanisms are also associated with increased platelet aggregation and hyperactivity and increase a patient's overall risk for cardiovascular morbidities.

Many patients with cardiovascular co-morbidities are taking aspirin for primary or secondary prevention. With a concomitant diagnosis of OSA, it is thought that these patients who are taking aspirin on a daily basis may become resistant to its effects based on how their OSA is controlled (ie. CPAP vs. Non-CPAP). Although aspirin resistance has been noted to be a "laboratory phenomenon," there have been studies which have shown a three-fold increase in cardiovascularco- morbidities in patients who were found to be aspirin resistant. In this study, it is our goal to determine the prevalence of aspirin resistance in patients who have a diagnosis of OSA and undergoing treatment with CPAP or Non-CPAP methods by measuring Aspirin Resistant Units (ARUs) using light aggregometry. It is our overall objective to determine whether or not OSA is an independent risk factor for aspirin resistance.

OSA patients are at increased risk of major cardiovascular events and aspirin resistance is associated with poor cardiovascular outcomes. Studying aspirin responsiveness in OSA patients may help to elucidate the potential role of platelet function testing, including the possible clinical implications of an aspirin therapy regimen guided by platelet function testing.

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Aspirin Resistance in Obstructive Sleep Apnea Patients (ARISA Trial)
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : September 7, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
Control - No Obstructive Sleep Apnea with Aspirin

The control group consist of patients with a negative diagnosis of OSA (based on a negative home sleep apnea test (REI) < 5 and attended sleep study, AHI < 5; or attended NPSG with an AHI < 5) and the patient is taking aspirin at a dose of 81 mg/day for at least a week prior to inclusion.

After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture.

Other: Aspirin Resistance testing
Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)

Arm 1- Obstructive Sleep Apnea with CPAP therapy and Aspirin

Arm 1 consist of patients with a diagnosis of OSA (based on home or attended sleep study) with an REI/AHI > 15 with or without symptoms or REI/AHI > 5 with symptoms of sleep apnea in a patient 18-85 years old, CPAP has been started within the last 2 years, and patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment.

After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture.

Other: Aspirin Resistance testing
Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)

Arm 2 -Obstructive Sleep Apnea with no CPAP & Aspirin

Arm 2 consist of patients with a diagnosis of OSA (based on home or attended sleep study) with an REI/AHI > 15 with or without symptoms or REI/AHI > 5 with symptoms of sleep apnea in a patient 18-85 years old and patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment.

After obtaining written informed consent, approximately 6 ml of blood was collected via venipuncture.

Other: Aspirin Resistance testing
Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)




Primary Outcome Measures :
  1. The prevalence of aspirin resistance in patients with newly diagnosed OSA taking aspirin for primary or secondary prevention. [ Time Frame: Immediately after consent is obtained (baseline) ]
    The prevalence of aspirin resistance, measured by platelet aggregometry, in patients with newly diagnosed OSA who take aspirin for primary or secondary prevention.


Secondary Outcome Measures :
  1. The prevalence of aspirin resistance in OSA patients who take aspirin for primary or secondary prevention and are currently being treated with CPAP. [ Time Frame: Immediately after consent is obtained (baseline) ]
    The prevalence of aspirin resistance in those patients with OSA on aspirin for primary or secondary prevention who are currently being treated with CPAP.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who come to the WCHN Pulmonary and Sleep Medicine Clinic either for a follow-up appointment to monitor their therapy for OSA or for an appointment to discuss a new diagnosis of OSA referred by their pulmonologist.
Criteria

Inclusion Criteria for Control Group:

  • No OSA (based on home or attended polysomnography) determined by negative sleep study (HSAT or NPSG) REI/AHI < 5 (if a home study was done and found negative or equivocal an attended study is required to rule out sleep apnea)
  • Patient is taking aspirin at a dose of 81 mg/day for at least a week last dose taken within 24 hours prior to enrollment.

Inclusion Criteria for "CPAP-Naïve" Cohort:

  • Diagnosis of OSA (based on home or attended sleep study) with an REI/AHI ≥ 15 with or without symptoms or REI/AHI ≥ 5 with symptoms of sleep apnea in a patient 18-85 years old.
  • Patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment.

Inclusion Criteria for "CPAP-treated" Cohort:

  • Diagnosis of OSA (based on home or attended sleep study) with an REI/AHI ≥ 15 with or without symptoms or REI/AHI ≥ 5 with symptoms of sleep apnea in a patient 18-85 years old.
  • CPAP has been started within the last 2 years
  • Patient is taking aspirin at a dose of 81mg/day for at least a week, last dose taken within 24 hours prior to enrollment.

Exclusion Criteria for all cohorts including control group:

  • Patient is not able to provide informed consent
  • Patient has taken at least one dose of a non-aspirin NSAID within the last 3 days
  • Patient has taken at least one dose of another (non-aspirin) anti-platelet agent(s) (clopidogrel, abciximab, eptifibatide, tirofiban, cilostazol, dipyridamole, prasugrel, ticlopidine, ticagrelor) in the last 7 days.
  • Patient has taken at least one dose of vitamin K antagonist (warfarin) in the last 7 days or heparin (low molecular weight or unfractionated) in the last 24 hours
  • Patient has taken steroids (intravenous, oral, or topical) within the last 2 weeks
  • Signs and symptoms of an active infection:
  • Temperature ≥ 100.4
  • Productive cough
  • Rhinorrhea
  • Dysuria
  • Diarrhea
  • Signs and symptoms of a local inflammatory reaction
  • Pain
  • Warmth
  • Erythema
  • Swelling
  • Any history of a systemic inflammatory disorder
  • Any history of diabetes mellitus if no HbA1C measurement obtained within 6 months is available; if HbA1C measurement obtained within 6 months is available, patient will be included.
  • Any history of chronic kidney disease
  • Pregnant women, and women in labor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930875


Locations
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United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Sponsors and Collaborators
Danbury Hospital
Accriva Diagnostics
Investigators
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Principal Investigator: Jose L Mendez Western Connecticut Health Network
Publications:

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Responsible Party: Jose Luis Mendez, Physician, Department of Pulmonary, Danbury Hospital
ClinicalTrials.gov Identifier: NCT03930875    
Other Study ID Numbers: 17-08-229-337
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics