Aspirin Resistance in OSA Patients

April 26, 2019 updated by: Jose Luis Mendez, Danbury Hospital

Aspirin Resistance in Obstructive Sleep Apnea Patients (ARISA Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after consent is obtained (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after consent is obtained (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danbury Hospital

Collaborators

Accriva Diagnostics

Investigators

  • Principal Investigator: Jose L Mendez, Nuvance Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2017

Primary Completion (Actual)

September 7, 2018

Study Completion (Actual)

September 7, 2018

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-08-229-337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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