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
  Purpose

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.


Condition
Coronary Artery Disease
Myocardial Infarction
Diabetes Mellitus
Renal Insufficiency, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is a Reduced Biochemical Response to Aspirin Associated With Increased Cardiovascular Morbidity and Mortality in High Risk Patients With Coronary Artery Disease?

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke [ Time Frame: Evaluation after 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, urine


Enrollment: 906
Study Start Date: November 2007
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT01383304

Locations
Denmark
Department of Clinical Biochemistry, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Danish Heart Foundation
Investigators
Principal Investigator: Anne-Mette Hvas, MD, Ph.D Department of Clinical Biochemistry, Aarhus University Hospital, Skejby, Denmark
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01383304     History of Changes
Other Study ID Numbers: 22527
Study First Received: June 22, 2011
Last Updated: January 10, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Platelet aggregation
Aspirin
Drug resistance
Thromboxane B2
Pharmacologic Actions
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Infarction
Myocardial Infarction
Myocardial Ischemia
Renal Insufficiency
Renal Insufficiency, Chronic
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Ischemia
Kidney Diseases
Metabolic Diseases
Necrosis
Pathologic Processes
Urologic Diseases
Vascular Diseases
Aspirin
Platelet Aggregation Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 20, 2014