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The influence of statin therapy on DDAVP response in patients with Type 1 von Willebrand disease or mild Hemophilia A.

The STIMULATE study: Statins Influence on Minrin Upregulation of von Willebrand factor and factor VIII.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26976
Enrollment
20
Registered
2009-11-05
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand disease Ziekte van Von Willebrand Hemophilia A Hemofilie A Bloederziekte

Interventions

Two DDAVP infusions will be performed. The first DDAVP test will take place prior to starting statin therapy and the second test will be performed after 6 weeks of statin therapy. During both tests bl

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mild hemophilia A, or; 2. Type 1 von Willebrand disease; 3. DDAVP response has been tested at least once before; 4. Age: 18 – 60 years; 5. Male; 6. Written informed consent is given.

Exclusion criteria

Exclusion criteria: 1. Moderate/Severe hemophilia A; 2. Type 2 or 3 von Willebrand diseas; 3. Clinical history of any other hemostatic or thrombotic disorder; 4. Allergy or contra-indication for Simvastatine or Minrin therapy; 5. Medical indication for statin therapy; 6. Co-enrolment in other clinical study in the last 3 months; 7. No previous DDAVP-test; 8. First relative (brother/sister) participating in this study.

Design outcomes

Primary

MeasureTime frame
1. Von Willebrand factor antigen, von Willebrand factor activity and von Willebrand Factor propeptide plasma levels after DDAVP stimulation, during statin therapy; 2. Factor VIII activity and factor VIII antigen plasma levels after DDAVP stimulation, during statin therapy.

Secondary

MeasureTime frame
Von Willebrand factor multimers, ADAMTS13 and tPA plasmalevels after DDAVP stimulation during statin therapy.

Contacts

Public ContactC.L. Eckhardt

Meibergdreeg 9

C.L.Eckhardt@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)