Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registration of Idarucizumab for Patients With IntraCranial Hemorrhage (RIC-ICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062097
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hans Diener, University Hospital, Essen

Brief Summary:
This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".

Condition or disease Intervention/treatment
Intracranial Hemorrhage Drug: Dabigatran Etexilate Oral Capsule [Pradaxa] Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND] Drug: Vitamin K antagonist

Layout table for study information
Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Registration of Idarucizumab for Patients With IntraCranial Hemorrhage (RIC-ICH)
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
dabigatran-group
Patients with the anticoagulating therapy dabigatran and onset of clinically symptomatic intracranial hemorrhage, that is treated with idarucizumab.
Drug: Dabigatran Etexilate Oral Capsule [Pradaxa]
Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.

Drug: Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]
Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.

VKA-group
Patients under effective treatment with VKA and with intracranial hemorrhage.
Drug: Vitamin K antagonist
This drug group includes the active substances phenprocoumon and warfarin.




Primary Outcome Measures :
  1. Intra-hospital mortality rate [ Time Frame: From study inclusion until hospital discharge or 30 days after index event, whichever came first. ]
    Intra-hospital mortality rate


Secondary Outcome Measures :
  1. Change in National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: At hospital admission, 24 hours after admission and 72 hours after admission. ]
    Change in National Institutes of Health Stroke Scale (NIHSS) of ≥4 pts compared to initial NIHSS or worsening of NIHSS level of consciousness ≥1 point or increase of the volume of the intracranial bleeding or new intraventricular bleeding or death. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  2. Intracranial bleeding [ Time Frame: Between 24 and 72 hours after initial CT. ]
    Change in size/volume of > 33% or ≥ 6.5 ml of the intracranial bleeding evaluated by first CT

  3. Stroke severity [ Time Frame: 72 hours after hospital admission ]
    Change in stroke severity by ≥4 points based on National Institutes of Health Stroke Scale (NIHSS). The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

  4. Functional status [ Time Frame: At hospital discharge or 30 days after index event, whichever came first. ]
    Functional status according to modified Rankin Scale (mRS). The scale runs from 0-6, running from perfect health without symptoms to death: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.

  5. Mortality rate [ Time Frame: 7 and 30 days after index event. ]
    Mortality rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with the anticoagulating therapy dabigatran admitted with a clinically symptomatic intracranial bleeding will be included in the study, if they have been treated with idarucizumab (dabigatran-group). It is assumed that some of these patients will have been given an antiplatelet drug as co-medication.

As reference population, patients with intracranial hemorrhage under effective treatment with VKA (INR ≥ 1,7) treated in the same center will be used (VKA-group). These patients usually have been treated with some antagonist to VKA (or no reversal therapy at all).

Criteria

Inclusion Criteria (dabigatran-group):

  • Age ≥18 years at enrollment
  • Patients willing and able to provide written informed consent for data transmission (exceptions/special cases for patients who are not legally competent to sign informed consent for data transmission).
  • Patients with primary intracranial hemorrhage as confirmed with CT.
  • Patients under effective anticoagulation treatment with dabigatran at the time of admission (TT>60 sec. or last intake of medication <24hours).
  • Patients treated with Idarucizumab (2x2.5 g recommended) may still be included the day after the administration of Praxbind, or on the following working day if treatment was carried out on the weekend.
  • inclusion (signed informed consent) as soon as possible after start of symptoms of initial ICH event, but before discharge.

Inclusion Criteria (control-group):

- Patients with intracranial hemorrhage under effective anticoagulation treatment with VKA (INR ≥ 1,7) having been initially treated in the past in the study center.

Exclusion Criteria (dabigatran-group):

  • Additional therapy with PCC, aPCC or factor VII (in patients under dabigatran).

Exclusion Criteria (all patients):

- Start of symptoms of initial ICH event > 24 h before admission to hospital.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062097


Contacts
Layout table for location contacts
Contact: Hans Diener, Prof. Dr. +49 201 723 ext 6540 hans.diener@uk-essen.de

Sponsors and Collaborators
University Hospital, Essen
Investigators
Layout table for investigator information
Study Director: Hans Diener, Prof. Dr. University Hospital, Essen

Layout table for additonal information
Responsible Party: Prof. Dr. Hans Diener, Senior Professor of Clinical Neurosciences, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04062097     History of Changes
Other Study ID Numbers: RIC-ICH
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Hans Diener, University Hospital, Essen:
intracranial/intracerebral bleeding
stroke
transient ischemic attack (TIA)
myocardial infarction
anticoagulation
dabigatran
idarucizumab
vitamin-k antagonists
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Hemorrhages
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin K
Dabigatran
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants