STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII
- Conditions
- BloedstollingsstoornissenHemophilia AVon Willebrand Disease
- Registration Number
- NL-OMON32666
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
1. Mild hemophilia A: defined as a F VIII deficiency with a F VIII plasma concentration of 10-40 IU mL-1, confirmed on at least two occasions.
2. or Von Willebrand disease type 1: defined as a VWF deficiency with a VWF plasma concentration of 10-40 IU mL-1, confirmed on at least two occasions.
3. DDAVP response has been tested at least once before, VWF activity and VWF antigen after DDAVP should not exceed > 200 %.
4. Age: 18 * 60 years
5. Male
1. Moderate/Severe hemophilia A: defined as a F VIII deficiency with a F VIII:C plasma concentration of * 2 IU mL-1, confirmed at at least two occasions.
2. Von Willebrand disease type 2 or 3
3. Clinical history of any other hemostatic or thrombotic disorder.
4. Clinical history of any disorder specified in Appendix C of the study protocol
5. Use of any medications specified in Appendix C of the study protocol
6. Medical indication for statin therapy.
7. Co-enrolment other clinical study
8. DDAVP response has not previously been tested or vWF antigen and vWF activity increase after previous DDAVP exposure was less than two fold.
9. First relative (brother/sister) participating in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* vWF antigen, vWF activity and vWF propeptide plasma levels after DDAVP<br /><br>stimulation, during statin therapy.<br /><br>* FVIII activity and F VIII antigen plasma levels after DDAVP stimulation,<br /><br>during statin therapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* vWF multimers, ADAMTS13 and tPA plasmalevels after DDAVP stimulation during<br /><br>statin therapy.</p><br>