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Platelet reactivity in patients with Atrial Fibrillation and Coronary Artery Disease under IIa antagonists and Xa antagonists

Completed
Conditions
Atriumfibrilleren
Boezemfibrilleren
10007521
Registration Number
NL-OMON52390
Lead Sponsor
Sint Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

Patient must meet all of the following criteria:
• Male or female >= 18 years
• AF with stable coronary disease (either angiographically proven, undergone an
intervention or history of MI)
• Use of OAC(NOAC)
• Patients with signed informed consent

Exclusion Criteria

• Patients who are unable to give informed consent
• Patients with hematologic, renal (estimated glomerular filtration rate <45
ml/min/1.73m2), hepatic (liver enzymes >2 times the upper limit of normal),
inflammatory (CRP >2 times the upper limit of normal)or neoplastic disorders
• Patients using any other antithrombotic drugs (e.g., aspirin, GPIIbIIIa etc.)
• Patients using nonsteroidal anti-inflammatory drugs, corticosteroids, or
hormone replacement therapy
• Patients with valvular AF(either articfial heart valves, medium to severe
mitral valve stenosis or <3 months after bioprosthetic heart valves) and AF
precipitated by hyperthyroidism or any acute infection
• Patients with coronary disease resulting from demand ischaemia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>• Percentage platelet bound P-selectin expression</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>• Levels of Tromboxane B2<br /><br>• Platelet reactivity as measured with multiple platelet function tests<br /><br>(Appendix A)<br /><br>• Fibrinolysis activity as measured with Plasmin-antiplasmin complex (PAP),<br /><br>D-dimers and TAFIa levels as well as in vitro clot-lysis time between the three<br /><br>drugs will be contrasted.<br /><br>• Fibrin formation markers (fibrinopeptide A and B and soluble fibrin) and the<br /><br>in vitro clotting time<br /><br>• Overall thrombus formation and clot lysis assessment using<br /><br>thromboelastography (TEG) en T-TAS</p><br>
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