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STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII

Conditions
Bloedstollingsstoornissen
Hemophilia A
Von 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
<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
NameTimeMethod
<p>* vWF multimers, ADAMTS13 and tPA plasmalevels after DDAVP stimulation during<br /><br>statin therapy.</p><br>
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