Study endpoints: This study will capture the following endpoints: 1. To determine if use of IIa antagonist(Dabigatran) is associated with increased platelet activation as compared to Xa(Apixaban, edoxaban, rivaroxaban) 2. To determine if use of IIa…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Percentage platelet bound P-selectin expression
Secondary outcome
• Levels of Tromboxane B2
• Platelet reactivity as measured with multiple platelet function tests
(Appendix A)
• Fibrinolysis activity as measured with Plasmin-antiplasmin complex (PAP),
D-dimers and TAFIa levels as well as in vitro clot-lysis time between the three
drugs will be contrasted.
• Fibrin formation markers (fibrinopeptide A and B and soluble fibrin) and the
in vitro clotting time
• Overall thrombus formation and clot lysis assessment using
thromboelastography (TEG) en T-TAS
Background summary
This is a single blinded (investigators blinded) crossover trial of 40
patients, diagnosed with AF on a steady state level of an anticoagulant.
Patients will switch once medication after 2 weeks(IIa antagonist en Xa
antagonist). Platelet function tests and fibrinolysis tests will be performed
in blood samples collected at baseline(Before use of the medication) and after
2 weeks.
Study objective
Study endpoints: This study will capture the following endpoints:
1. To determine if use of IIa antagonist(Dabigatran) is associated with
increased platelet activation as compared to Xa(Apixaban, edoxaban,
rivaroxaban)
2. To determine if use of IIa antagonist(Dabigatran) is associated with
decreased fibrinolysis activation as compared to Xa(Apixaban, edoxaban,
rivaroxaban)
Study design
Prospective cross-over study.
Intervention
Use of Accenocoumarol, Apixaban and Dabigatran
Study burden and risks
All patients switch medication after 2 weeks and switch back. Besides regular
risks of use of registered medication(e.g. small bleedings and brushes) no
extra risks involved
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69712.100.19 |