E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients using acenocoumarol and planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed. |
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E.1.1.1 | Medical condition in easily understood language |
Adult patients treated with anticoagulatrion that are planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To identify which coagulation factors are involved in inadequate INR normalization after vitamin K administration 36-48 hours prior to invasive procedures in patients that continue acenocoumarol perioperatively. |
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E.2.2 | Secondary objectives of the trial |
- To assess the proportion of patients reaching target INR <1.8 at the day of the invasive procedure after the local procedure at ZGV.
- To assess the number of patients experiencing either thromboembolic or bleeding complications after the administration of 10 mg vitamin K.
- To assess the time between the invasive procedure and recovery of the INR to a therapeutic level after the local procedure.
- To store a whole blood sample from each patient for pharmacogenetics analyses, which can be used to correlate the change in coagulation factors to. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients on acenocoumarol requiring an invasive procedure. |
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E.4 | Principal exclusion criteria |
- Age < 18 years.
- Patients requiring periprocedural bridging therapy according to our local protocol based on national guidelines with low-molecular-weight-heparin (LMWH).
- Inherited or acquired coagulopathies.
- Inability or incompetency to give informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Prothrombin and factor VII activity at the day of the invasive procedure. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure. |
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E.5.2 | Secondary end point(s) |
- The number of patients with an INR <1.8 just prior to the invasive procedure.
- Number of thromboembolic or bleeding events occurring within 30 days after the intervention.
According to the International Society of Thrombosis and Haemostatis (ISTH) guidelines bleeding complications are defined as major if they are fatal, symptomatic bleeding intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and / or lead to fall In hemoglobin of 1.24 mmol/L or more, or leading to a blood transfusion of two or more units of whole blood or red cells.9 Also, thromboembolic events (such as deep venous thrombosis, TIA/stroke, peripheral embolism) are recorded.
- Time to achieve therapeutic INR in acenocoumarol users who are administered a single dose of vitamin K 36-48 hours before the invasive procedure. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Blood will be withdrawn 2 days before, at the day of and 1, 3 and 5 days after the invasive procedure. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |