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Contribution of coagulation and inflammation to the extent of atherosclerosis in patients with peripheral vascular disease


- candidate number28978
- NTR NumberNTR7250
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2018
- Secondary IDsNL63235.068.17 
- Public TitleContribution of coagulation and inflammation to the extent of atherosclerosis in patients with peripheral vascular disease
- Scientific TitleTarget finding for atherothrombosis in a population of patients diagnosed with peripheral obstructive arterial disease
- ACRONYMAtherothrombosis in PAD
- hypothesisOngoing activation of the haemostatic system and continuous inflammatory processes contribute to atherosclerotic progression and to the occurrence of atherothrombotic events in PAD.
- Healt Condition(s) or Problem(s) studiedAtherosclerosis , Peripheral Arterial Disease, Cardiovascular disease, Atherothrombosis
- Inclusion criteria- Patients diagnosed with peripheral artery disease, both new patients and patients currently in follow-up
- Patients who signed declaration of consent
- Patients who are at least 18 years of age and compos mentis
- Exclusion criteria- Usage of therapeutic doses of anticoagulants (vitamin K antagonists, direct oral anticoagulants, low molecular weight heparins)
- Pregnancy, oral contraceptives, hormone replacement therapy
- Chronic inflammatory diseases
- Anti-phospholipid syndrome
- Active malignancy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 20-apr-2018
- planned closingdate20-apr-2021
- Target number of participants315
- InterventionsNot applicable
- Primary outcomeNumber and type of atherothrombotic events: Coronary artery disease, myocardial infarction, stroke, limb ischemia, all-cause and cardiovascular mortality.
- Secondary outcome- Differences in coagulation and inflammation profile
- Differences in platelet reactivity
- Differences in medication adherence rate
- Sensitivity and specificity of a newly developed functional assay
- Timepoints- 0 months
- 3 months
- 6 months
- 12 months
- Trial web siteNot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. B. Kremer
- CONTACT for SCIENTIFIC QUERIESMD. PhD. B. Kremer
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Bayer AG
- PublicationsNot applicable
- Brief summaryCardiovascular disease is the number one cause of death in Europe. Peripheral artery disease is a collective name for all processes obstructing blood flow in arteries outside of the heart. It has been suggested in several studies that ongoing activation of the haemostatic system may contribute to atherosclerotic progression and to the occurrence of atherothrombotic events in peripheral artery disease.
- Main changes (audit trail)
- RECORD1-jun-2018 - 10-jun-2018


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