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Aspirin Resistance and Sleep Apnea (AREAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01788930
First received: February 7, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence up to 60%.

The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.

Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep apnea will be recruited after providing informed consent. Response to aspirin will be assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at baseline to determine their influence on the response to aspirin.

Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h)will be randomized to 3 months of active or sham continuous positive airway pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin will be compared between the sham and effective CPAP groups.


Condition Intervention
Atherothrombosis
Type 2 Diabetes
Obstructive Sleep Apnea Syndrome
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Response to antiplatelet therapy [ Time Frame: Measure will be done in the morning after the sleep diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of CPAP treatment for severe obstructive sleep apnea on aspirin efficacity in type-2 diabetic patients [ Time Frame: Change from baseline after 3 months randomized treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP

This device consists in a nasal continuous positive airway pressure (CPAP). It will be applied 3 months after the beginning of drug treatment and for 3 months.

Other Name: positive airway pressure

Device: CPAP
Placebo Comparator: Sham-CPAP
This device consists in a sham CPAP. It will be applied 3 months after the beginning of drug treatment and for 3 months.
Device: CPAP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged > 18 years old
  • With Type 2 diabetes
  • Stable Atherothrombosis for more than 3 months
  • Using aspirin for more than 10 days
  • Without any modification in their treatments for 10 days
  • Ambulatory patient
  • Without any cardiovascular event or inflammatory disease for 3 months before inclusion

Exclusion Criteria:

  • Pregnant women
  • Other active clinically significant illness, including unstable cardiovascular, or neoplasia which could interfere with the study conduct or counterindicate the study treatments or place the patient at risk during the trial or compromise the study participation
  • Patients participating in an other study
  • Patient without any medical care insurance
  • Any treatment that could interfere with aspirin
  • Previous treatment by CPAP
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788930

Contacts
Contact: Olivier ORMEZZANO, MD, PhD +33 4 76 76 75 75 OOrmezzano@chu-grenoble.fr
Contact: Jean-Louis PEPIN, MD, PhD + 33 4 76 76 55 16 JPepin@chu-grenoble.fr

Locations
France
Grenoble University Hospital Recruiting
Grenoble, Isere, France
Contact: Marie PEETERS    +334 76 76 92 65    MPeeters@chu-grenoble.fr   
Principal Investigator: Olivier ORMEZZANO, MD, PhD         
Sub-Investigator: Jean-Louis PEPIN, MD, PhD         
Sub-Investigator: Patrick LEVY, MD, PhD         
Sub-Investigator: Renaud TAMISIER, MD, PhD         
Sub-Investigator: Sandrine LAUNOIS, MD, PhD         
Sub-Investigator: Pierre-Yves BENHAMOU, MD, PhD         
Sub-Investigator: Anne-Laure BOREL, MD, PhD         
Sub-Investigator: Nelly WION-BARBOT, MD, PhD         
Sub-Investigator: Patrice FAURE, MD, PhD         
Sub-Investigator: Françoise STANKE, MD, PhD         
Sub-Investigator: Jean-Philippe BAGUET, MD, PhD         
Sub-Investigator: Gérald VANZETTO, MD, PhD         
Sub-Investigator: Patrick CARPENTIER, MD, PhD         
Sub-Investigator: Christophe SEINTURIER, MD, PhD         
Sub-Investigator: Jacqueline YVER, MD, PhD         
Sub-Investigator: Gilles PERNOD, MD, PhD         
Sub-Investigator: Benoit POLACK, MD, PhD         
Sub-Investigator: Raphael MARLU, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Olivier ORMEZZANO, MD, PhD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01788930     History of Changes
Other Study ID Numbers: 1227
Study First Received: February 7, 2013
Last Updated: February 7, 2013
Health Authority: France: 'French National Agency for Drug Safety'

Additional relevant MeSH terms:
Apnea
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus
Dyssomnias
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014