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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2094 |
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Date of registration:
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05/11/2009 |
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Primary sponsor: |
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Public title:
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The influence of statin therapy on DDAVP response in patients with Type 1 von Willebrand disease or mild Hemophilia A.
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Scientific title:
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The STIMULATE study: Statins Influence on Minrin Upregulation of von Willebrand factor and factor VIII. - STIMULATE |
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Date of first enrolment:
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1/1/2010 |
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Target sample size:
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20 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2094 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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C.L.
Eckhardt |
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Address:
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Meibergdreeg 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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Email:
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C.L.Eckhardt@amc.uva.nl |
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Affiliation:
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Name:
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C.L.
Eckhardt |
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Address:
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Meibergdreeg 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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Email:
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C.L.Eckhardt@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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, Von Willebrand Disease, Hemophily A
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Intervention(s)
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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 blood samples will be taken until 32 hours after DDAVP infusion (in total 7 times per test). In each bloodsample e.g. vWF activity and F VIII activity will be determined.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Von Willebrand factor multimers, ADAMTS13 and tPA plasmalevels after DDAVP stimulation during statin therapy.
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Secondary ID(s)
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2009-017060-17
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Source(s) of Monetary Support
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Academic Medical Center (AMC)
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