Aspirin Resistance in OSA Patients

NCT03930875 | Completed

• 1 other identifier: 17-08-229-337
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• The prevalence of aspirin resistance in patients with newly diagnosed OSA taking aspirin for primary or secondary prevention.

  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 Outcomes (1)

• The prevalence of aspirin resistance in OSA patients who take aspirin for primary or secondary prevention and are currently being treated with CPAP.

  Immediately after consent is obtained (baseline)

Study Arms (3)

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

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

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

Interventions

Aspirin Resistance testing OTHER

Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)

Arm 1- Obstructive Sleep Apnea with CPAP therapy and Aspirin; Arm 2 -Obstructive Sleep Apnea with no CPAP & Aspirin; Control - No Obstructive Sleep Apnea with Aspirin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danbury Hospital: lead
• Accriva Diagnostics: collaborator

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jose L Mendez

  Nuvance Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Pulmonary

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: December 12, 2017
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)