EUCTR2009-017060-17-NL进行中（未招募）不适用
STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIII - STIMULATE
Academic Medical Center0 个研究点开始时间: 2009年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
- •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
排除标准
- •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
- •- 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
研究者
相似试验
尚未招募
不适用
STIMULATE study: Statins influence on Minrin upregulation of von Willebrand factor and factor VIIIBloedstollingsstoornissenVon Willebrand DiseaseHemophilia ANL-OMON32666Academisch Medisch Centrum20
尚未招募
不适用
The influence of statin therapy on DDAVP response in patients with Type 1 von Willebrand disease or mild Hemophilia A.NL-OMON26976Academic Medical Center, Amsterdam20
招募中
3 期
Investigating the therapeutic effect of statin relative to the N-acetyl cysteine in the treatment of Helicobacter pylori patientsHelicobacter pylori patients.IRCT20231017059756N1Mashhad University of Medical Sciences180
已完成
3 期
Evaluation of the effect of very high dose atorvastatin on candidates for elective angioplastyAcute myocardial infarction after elective stenting, contrast-induced nephropathy after elective stenting.Atherosclerotic heart disease, Old myocardial infarctionI25.1, I25IRCT2017011831073N2Tehran University of Medical Sciences340
招募中
3 期
statin in PVR related redetachmentIRCT20191207045645N1Vice Chancellor for Research, Iran University of Medical Sciences110