E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acquired type 2A von Willebrand syndrome is common in patients with severe aortic valve stenosis (AS). It originates from the mechanical obstruction of blood flow and the consecutive proteolysis of von vWF (von Willebrand factor) as it passes through the stenotic valve. Type 2A von Willebrand syndrome (vWS) is characterized by the loss of the largest multimers of vWF, which are the most effective in platelet-mediated hemostasis under conditions of high shear stress. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
We are interested whether DDAVP favorably affects
vWF related parameters ( see 3.6. primary efficiacy endpoints ) and their perioperative recovery postoperative blood loss (collected over 48 hrs into chest tube drains ) perioperative blood component use in patients with AS related acquired vWS (pre-trial screening )
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E.2.2 | Secondary objectives of the trial |
correlation of potential postoperative aortic valve restenosis and abnormalities of vWF related parameters.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Signed informed consent form before trial-related activities Patients undergoing elective bioprosthetic aortic valve replacement
Left ventricular ejection fraction > 40%
Patients aged 18 and 90 years
Prolonged closure time PFA-100 (ADP)> 170 (s).
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E.4 | Principal exclusion criteria |
Participation in another clinical trial Incompetence to give consent (language and comprehension) Active endocarditis Association with coronary artery disease Multivalvular disease Antiplatelet treatment that could not be stopped 7 days before surgery Pregnancy or child-bearing potential BMI > 40 kg/m2 Serum creatinine > 1.5 mg/dL Known hypersensitivity towards DDAVP
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E.5 End points |
E.5.1 | Primary end point(s) |
von Willebrand factor antigen (vWF:Ag)
Ristocetincofactor/ von Willebrand factor antigen ratio
Closure time (PFA-100) Collagen Adenosin 5-diphosphate closure time, (CAPD-CT) Collagen Epinephrine closure time (CEPI-CT) (s) vWF collagen-binding activity (vWF:CBA)
von Willebrand factor ristocetin cofactor percentage of highest molecular-weight multimers
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After 60 patients trial will be finished. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |