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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01383304
Other study ID # 22527
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 22, 2011
Last updated May 11, 2016
Start date November 2007
Est. completion date January 2017

Study information

Verified date May 2015
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 906
Est. completion date January 2017
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Denmark Department of Clinical Biochemistry, Aarhus University Hospital, Skejby Aarhus N

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital Skejby, Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Grove EL, Hvas AM, Johnsen HL, Hedegaard SS, Pedersen SB, Mortensen J, Kristensen SD. A comparison of platelet function tests and thromboxane metabolites to evaluate aspirin response in healthy individuals and patients with coronary artery disease. Thromb Haemost. 2010 Jun;103(6):1245-53. doi: 10.1160/TH09-08-0527. Epub 2010 Mar 29. — View Citation

Hedegaard SS, Hvas AM, Grove EL, Refsgaard J, Rocca B, Daví G, Kristensen SD. Optical platelet aggregation versus thromboxane metabolites in healthy individuals and patients with stable coronary artery disease after low-dose aspirin administration. Thromb Res. 2009 May;124(1):96-100. doi: 10.1016/j.thromres.2008.12.034. Epub 2009 Feb 11. — View Citation

Larsen SB, Neergaard-Petersen S, Grove EL, Kristensen SD, Hvas AM. Increased platelet aggregation and serum thromboxane levels in aspirin-treated patients with prior myocardial infarction. Thromb Haemost. 2012 Jul;108(1):140-7. doi: 10.1160/TH12-01-0026. — View Citation

Mortensen SB, Larsen SB, Grove EL, Kristensen SD, Hvas AM. Reduced platelet response to aspirin in patients with coronary artery disease and type 2 diabetes mellitus. Thromb Res. 2010 Oct;126(4):e318-22. doi: 10.1016/j.thromres.2010.03.013. Epub 2010 May 7. — View Citation

Nielsen HL, Kristensen SD, Thygesen SS, Mortensen J, Pedersen SB, Grove EL, Hvas AM. Aspirin response evaluated by the VerifyNow Aspirin System and light transmission aggregometry. Thromb Res. 2008;123(2):267-73. doi: 10.1016/j.thromres.2008.03.023. Epub 2008 May 21. — View Citation

Pedersen SB, Grove EL, Nielsen HL, Mortensen J, Kristensen SD, Hvas AM. Evaluation of aspirin response by Multiplate whole blood aggregometry and light transmission aggregometry. Platelets. 2009 Sep;20(6):415-20. doi: 10.1080/09537100903100643. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Genotype according to pre-specified genetic single nucleotide polymorphisms (SNPs) 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. Baseline No
Primary Combined primary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke Evaluation after 3 years No
Secondary Combined secondary endpoint: Cardiovascular death, acute myocardial infarction, ischaemic stroke Evaluation after 5 years No
Secondary Single endpoints:cardiovascular death; acute myocardial infarction; ischemic stroke; stent thrombosis; all-cause death Evaluation after 3 and 5 years No
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