Aspirin Response in High Risk Patients With Coronary Artery Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aarhus University Hospital Skejby
Danish Heart Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01383304
First received: June 22, 2011
Last updated: January 10, 2014
Last verified: January 2014

June 22, 2011
January 10, 2014
November 2007
January 2011   (final data collection date for primary outcome measure)
Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke [ Time Frame: Evaluation after 3 years ] [ Designated as safety issue: No ]
  • Acute myocardial infarction [ Time Frame: Within a 2 year period ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: Within a 2 year period ] [ Designated as safety issue: No ]
  • Ischemic stroke [ Time Frame: Within a 2 year period ] [ Designated as safety issue: No ]
  • Revascularization due to unstable angina pectoris [ Time Frame: Within a 2 year period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01383304 on ClinicalTrials.gov Archive Site
  • Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke [ Time Frame: Evaluation after 5 years ] [ Designated as safety issue: No ]
  • Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death [ Time Frame: Evaluation after 3 and 5 years ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: Within a 5 year period ] [ Designated as safety issue: No ]
  • Acute myocardial infarction [ Time Frame: Within a 5 year period ] [ Designated as safety issue: No ]
  • Ischemic stroke [ Time Frame: Within a 5 year period ] [ Designated as safety issue: No ]
  • Revascularization due to unstable angina pectoris [ Time Frame: Within a 5 year period ] [ Designated as safety issue: No ]
Genotype according to pre-specified genetic single nucleotide polymorphisms (SNPs) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
At the day of blood sampling, plasma samples are retrieved for DNA extraction. DNA samples are used to evaluate if pre-specified genetic single nucleotide polymorphisms (SNPs) are associated with platelet aggregation levels.
Not Provided
 
Aspirin Response in High Risk Patients With Coronary Artery Disease
Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?

Previous studies indicate that patients with cardiovascular disease have a variable response to aspirin. Despite treatment with aspirin a large number of patients suffer a myocardial infarction. This has given rise to the phenomenon "aspirin low-responsiveness". Laboratory aspirin low-responsiveness can be defined as the failure of aspirin to inhibit platelet production of thromboxane A2 or inhibit thromboxane-dependent platelet aggregation. Whether a low platelet response to aspirin results in an increased risk of future thrombotic events is of great clinical significance, but is still unknown.

The investigators hypothesize that patients with a reduced response to aspirin, determined by platelet aggregation using the apparatus Verify Now Aspirin and Multiplate, have a higher risk of thrombosis.

The purpose of this study is to investigate whether a higher incidence of cardiovascular events is found in patients with coronary artery disease (CAD) having a reduced biochemical response to aspirin compared with CAD patients having a normal biochemical response to aspirin. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, plasma, urine

Non-Probability Sample

906 patients with CAD. In addition to CAD, all patients have at least one of the following risc factors: previous myocardial infarction, type 2 diabetes mellitus and/or renal insufficiency.

Eligible patients are identified in the Western Denmark Heart Registry.

  • Coronary Artery Disease
  • Myocardial Infarction
  • Diabetes Mellitus
  • Renal Insufficiency, Chronic
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
906
January 2015
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coronary artery disease verified by coronary angiogram
  • Treatment with aspirin 75 mg/d for at least the previous 7 days
  • Previous myocardial infarction more than one year ago (groups with previous myocardial infarction)
  • Type 2 diabetes mellitus treated with oral antidiabetics and/or insulin (groups with type 2 diabetes mellitus)
  • Renal insufficiency; glomerular filtration rate <60 ml/min at the time of blood sampling (groups with renal insufficiency)

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
  • Platelet count <120 x 10^9/L or >450 x 10^9/L
  • For patients without diabetes: fast glucose >7 mmol/L
  • Unable to give informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01383304
22527
No
University of Aarhus
University of Aarhus
  • Aarhus University Hospital Skejby
  • Danish Heart Foundation
Principal Investigator: Anne-Mette Hvas, MD, Ph.D Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark
University of Aarhus
January 2014

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