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

• Conditions: Type 1 von Willebrand disease and mild hemophilia A

• Registration Number: EUCTR2009-017060-17-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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 previous DDAVP infusion should be at least two fold increased and should not exceed > 200 %.

4. Age: 18 – 60 years

5. Male

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 of the following medical conditions:
- Allergy for Simvastatin of DDAVP
- Habitual or psychogenic polydipsia
- Serious heart failure of other disorders requiring treatment with diuretics
- Cardiovascular disease
- (Predisposition of) hyponatriëmia
- SIADH
- Angina pectoris
- Cystic fibrosis
- Current infection (temperature > 38,0 degrees Celcius or clinical manifestations of infection)
- (history of) alcohol abuse, defined as more than 21 units/week
- Hypothyrodism, not adequately treated
- Familiar muscle disorders
- Liver function disorder defined as the upper normal limit of ALAT and ASAT
- CPK above three times upper normal limit
- Renal impairment
- Diabetes mellitus type I and II

5. Use of any of the following medications:
- Indometacine or other prostaglandin synthesis inhibitors
- Tricyclic antidepressiva, SSRI's, chloorpromazine and carbamazepine or other
medications that disrupt the release of anti-diuretic hormone
- Loperamide
- CYP3A4-inhibitors

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this project is to gain insight in influence of Simvastatin therapy on DDAVP stimulated increase of von Willebrand factor and Factor VIII in patients with mild hemophilia A and von Willebrand disease type I ;Secondary Objective: None;Primary end point(s): Plasma levels of von Willebrand Factor antigen, von Willebrand factor activity and factor VIII activity after DDAVP stimulation during statin therapy. <br>