Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
63 participants
OBSERVATIONAL
2017-12-12
2018-09-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mechanism Based Resistance to Aspirin
NCT00948987
Danish Aspirin Resistance Trial - Pilot Study
NCT00389129
Aspirin Responsiveness in Women at Risk for Cardiac Events
NCT00818337
Intermittent or Continuous Acetylsalicylic Acid and Gene Expression in the Nasal Tissue of Current Smokers
NCT02123849
Long-term Aspirin Therapy as a Predictor of Decreased Susceptibility to SARS-CoV-2 Infection in Aspirin-Exacerbated Respiratory Disease
NCT05797597
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
Aspirin Resistance testing
Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aspirin Resistance testing
Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Accriva Diagnostics
INDUSTRY
Danbury Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jose Luis Mendez
Physician, Department of Pulmonary
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose L Mendez
Role: PRINCIPAL_INVESTIGATOR
Nuvance Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Danbury Hospital
Danbury, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
Maeder MT, Schoch OD, Rickli H. A clinical approach to obstructive sleep apnea as a risk factor for cardiovascular disease. Vasc Health Risk Manag. 2016 Mar 21;12:85-103. doi: 10.2147/VHRM.S74703. eCollection 2016.
Tazbirek M, Slowinska L, Kawalski M, Pierzchala W. The rheological properties of blood and the risk of cardiovascular disease in patients with obstructive sleep apnea syndrome (OSAS). Folia Histochem Cytobiol. 2011;49(2):206-10. doi: 10.5603/fhc.2011.0028.
Oga T, Chin K, Tabuchi A, Kawato M, Morimoto T, Takahashi K, Handa T, Takahashi K, Taniguchi R, Kondo H, Mishima M, Kita T, Horiuchi H. Effects of obstructive sleep apnea with intermittent hypoxia on platelet aggregability. J Atheroscler Thromb. 2009;16(6):862-9. doi: 10.5551/jat.2188. Epub 2009 Dec 22.
Kuliczkowski W, Witkowski A, Polonski L, Watala C, Filipiak K, Budaj A, Golanski J, Sitkiewicz D, Pregowski J, Gorski J, Zembala M, Opolski G, Huber K, Arnesen H, Kristensen SD, De Caterina R. Interindividual variability in the response to oral antiplatelet drugs: a position paper of the Working Group on antiplatelet drugs resistance appointed by the Section of Cardiovascular Interventions of the Polish Cardiac Society, endorsed by the Working Group on Thrombosis of the European Society of Cardiology. Eur Heart J. 2009 Feb;30(4):426-35. doi: 10.1093/eurheartj/ehn562. Epub 2009 Jan 27.
Cai G, Zhou W, Lu Y, Chen P, Lu Z, Fu Y. Aspirin resistance and other aspirin-related concerns. Neurol Sci. 2016 Feb;37(2):181-9. doi: 10.1007/s10072-015-2412-x. Epub 2015 Nov 14.
Gum PA, Kottke-Marchant K, Welsh PA, White J, Topol EJ. A prospective, blinded determination of the natural history of aspirin resistance among stable patients with cardiovascular disease. J Am Coll Cardiol. 2003 Mar 19;41(6):961-5. doi: 10.1016/s0735-1097(02)03014-0.
Lee PY, Chen WH, Ng W, Cheng X, Kwok JY, Tse HF, Lau CP. Low-dose aspirin increases aspirin resistance in patients with coronary artery disease. Am J Med. 2005 Jul;118(7):723-7. doi: 10.1016/j.amjmed.2005.03.041.
Grinstein J, Cannon CP. Aspirin resistance: current status and role of tailored therapy. Clin Cardiol. 2012 Nov;35(11):673-81. doi: 10.1002/clc.22031. Epub 2012 Jun 27.
Cheng G, Shan J, Xu G, Liu P, Zhou Y, Zhu Y, Lu X. Relationship between endothelial dysfunction, oxidant stress and aspirin resistance in patients with stable coronary heart disease. J Clin Pharm Ther. 2007 Jun;32(3):287-92. doi: 10.1111/j.1365-2710.2007.00823.x.
Hopps E, Caimi G. Obstructive Sleep Apnea Syndrome: Links Betwen Pathophysiology and Cardiovascular Complications. Clin Invest Med. 2015 Dec 4;38(6):E362-70. doi: 10.25011/cim.v38i6.26199.
Barbe F, Duran-Cantolla J, Sanchez-de-la-Torre M, Martinez-Alonso M, Carmona C, Barcelo A, Chiner E, Masa JF, Gonzalez M, Marin JM, Garcia-Rio F, Diaz de Atauri J, Teran J, Mayos M, de la Pena M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.
Buchner NJ, Sanner BM, Borgel J, Rump LC. Continuous positive airway pressure treatment of mild to moderate obstructive sleep apnea reduces cardiovascular risk. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1274-80. doi: 10.1164/rccm.200611-1588OC. Epub 2007 Aug 2.
Sokucu SN, Ozdemir C, Dalar L, Karasulu L, Aydin S, Altin S. Complete blood count alterations after six months of continuous positive airway pressure treatment in patients with severe obstructive sleep apnea. J Clin Sleep Med. 2014 Aug 15;10(8):873-8. doi: 10.5664/jcsm.3958.
Varol E, Ozturk O, Yucel H, Gonca T, Has M, Dogan A, Akkaya A. The effects of continuous positive airway pressure therapy on mean platelet volume in patients with obstructive sleep apnea. Platelets. 2011;22(7):552-6. doi: 10.3109/09537104.2011.578182. Epub 2011 May 19.
Krasopoulos G, Brister SJ, Beattie WS, Buchanan MR. Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis. BMJ. 2008 Jan 26;336(7637):195-8. doi: 10.1136/bmj.39430.529549.BE. Epub 2008 Jan 17.
Schwammenthal Y, Tsabari R, Shenkman B, Schwartz R, Matetzky S, Lubetsky A, Orion D, Israeli-Korn S, Chapman J, Savion N, Varon D, Tanne D. Aspirin responsiveness in acute brain ischaemia: association with stroke severity and clinical outcome. Cerebrovasc Dis. 2008;25(4):355-61. doi: 10.1159/000118382. Epub 2008 Feb 28.
Ozben S, Ozben B, Tanrikulu AM, Ozer F, Ozben T. Aspirin resistance in patients with acute ischemic stroke. J Neurol. 2011 Nov;258(11):1979-86. doi: 10.1007/s00415-011-6052-7. Epub 2011 Apr 21.
Pasala T, Hoo JS, Lockhart MK, Waheed R, Sengodan P, Alexander J, Gandhi S. Aspirin Resistance Predicts Adverse Cardiovascular Events in Patients with Symptomatic Peripheral Artery Disease. Tex Heart Inst J. 2016 Dec 1;43(6):482-487. doi: 10.14503/THIJ-14-4986. eCollection 2016 Dec.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-08-229-337
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.