Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laboratory Aspirin Resistance in Diabetics and Non-Diabetics

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: NCT00563875
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : June 10, 2008
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE November 23, 2007
First Posted Date  ICMJE November 26, 2007
Last Update Posted Date June 10, 2008
Study Start Date  ICMJE November 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2007)
Platelet aggregation [ Time Frame: (at least) one hour after aspirin ingestion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00563875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laboratory Aspirin Resistance in Diabetics and Non-Diabetics
Official Title  ICMJE Laboratory Aspirin Resistance in Coronary Artery Disease Patients With or Without Diabetes Mellitus
Brief Summary Despite treatment with aspirin a large number of patients suffer a myocardial infarction. It has been speculated that these patients might be "resistant" to aspirin, and studies have indicated that this phenomenon is related to a less favourable prognosis. Furthermore, patients with diabetes mellitus have an increased risk of myocardial infarction and other vascular events and, recently, it has been suggested that diabetics do not respond adequately to aspirin. The purpose of this study is to compare the prevalence of "aspirin resistance" in diabetics and non-diabetics. Furthermore, patients who suffered a myocardial infarction while being treated with aspirin are included. We hypothesize that the prevalence of "aspirin resistance" will be higher among diabetics compared to other patients and to healthy individuals.
Detailed Description A considerable number of patients suffer acute coronary events despite being treated with antiplatelet therapy such as aspirin. Taken together with laboratory findings of a low response to aspirin, the term "aspirin resistance" has been coined. Diabetics have an increased risk of suffering ischemic vascular events and, recently, an increased prevalence of "aspirin resistance" was reported in these patients. The purpose of the present study is to compare the aspirin response in diabetics and non-diabetics in a population with angiogram-verified coronary artery disease. Furthermore, healthy volunteers and patients who suffered a myocardial infarction while being treated with aspirin are included. Eligible patients are identified in the Western Denmark Heart Registry.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Drug Resistance
Intervention  ICMJE Drug: acetylsalicylic acid
75 mg/d for 7 days (healthy volunteers) and continued treatment with 75 mg/d in patients taking daily aspirin.
Other Name: Hjerdyl (Sandoz)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 23, 2007)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ischemic heart disease verified by coronary angiogram (group:"CAD")
  • treatment with aspirin 75 mg/d for at least the previous 7 days(groups: "CAD" and "Previous myocardial infarction")
  • type II diabetes mellitus (~50% of groups: "CAD" and "Previous myocardial infarction")
  • ≥ 1 myocardial infarction more than one year ago while taking daily aspirin ≥ 75 mg/d (group: "Previous myocardial infarction").

Exclusion Criteria:

  • treatment with NSAIDs, clopidogrel, ticlopidine, dipyridamole, warfarin or any other drugs known to affect platelet function.
  • ischemic vascular event within the previous 12 months
  • revascularization (angioplasty or coronary by-pass graft surgery) within the previous 12 months
  • intake of NSAIDs within 1 week of myocardial infarction (group: "Previous myocardial infarction").
  • platelet count < 120 x 10^9/l
  • previous myocardial infarction (group: "CAD").
  • not able to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00563875
Other Study ID Numbers  ICMJE 20070180
DDPA-2007-41-1207
DRA-2101-05-0052
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steen Dalby Kristensen, Aarhus University Hospital Skejby
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steen D Kristensen, M.D., DMSc Aarhus University Hospital
PRS Account University of Aarhus
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP