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Study of Antithrombotic Treatment After IntraCerebral Haemorrhage (STATICH)

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ClinicalTrials.gov Identifier: NCT03186729
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eivind Berge, Oslo University Hospital

Brief Summary:
The study evaluates the effects of antithrombotic drugs (anticoagulant drugs or antiplatelet drugs) for prevention of ischaemic events in patients With recent intracerebral haemorrhage.

Condition or disease Intervention/treatment Phase
Cerebral Hemorrhage Intracranial Hemorrhages Atrial Fibrillation Anticoagulant-Induced Bleeding Secondary Prevention Drug: Antithrombotic Agent Phase 4

Detailed Description:

Patients with spontaneous ICH have an increased risk of recurrent ICH and they also have an increased risk of ischaemic diseases. Around 40-50% of patients use, or have an indication, for antithrombotic drugs at the time of ICH. However, little is known about the benefits and harms of using antithrombotic drugs for prevention of ischaemic events in patients who have had an ICH.

There are only observational studies addressing this question. Because of the lack of randomised-controlled trials and the inconclusive findings of the observational studies, guidelines have variably endorsed both starting and avoiding antithrombotic drugs after ICH.

The investigators therefore want to study the effect and safety of using antithrombotic drugs after ICH. Furthermore, since findings on MRI can be biomarkers for subsequent bleeding, there will also be performed a sub-study of the association between such findings on MRI and risk of recurrent ICH during treatment with antithrombotic drugs.

Patients with ICH during the last 6 months and with an indication for antithrombotic drugs will be included. Patients with vascular disease and indication for antiplatelet drugs will be randomised to antiplatelet treatment vs. no antithrombotic treatment. Patients with atrial fibrillation and indication for anticoagulant treatment will be randomised to anticoagulant treatment vs. no anticoagulant treatment. The follow up period is 2 years, and the primary effect variable is new ICH. The investigators will also assess new intracranial haemorrhage, extracranial haemorrhage and ischemic events, and functional and cognitive outcome.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised-controlled trial, parallel groups
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2031

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antithrombotic treatment
For patients with vascular disease and indication for antiplatelet drugs: Antiplatelet drugs; For patients with atrial fibrillation and indication for anticoagulant drugs: Anticoagulant drugs
Drug: Antithrombotic Agent
Anticoagulant or antiplatelet drugs

No Intervention: No antithrombotic treatment
For patients with indication for antiplatelet drugs: No antithrombotic drugs For patients with atrial fibrillation and indication for anticoagulant drugs: No anticoagulant drugs.



Primary Outcome Measures :
  1. Fatal or non-fatal symptomatic ICH. [ Time Frame: 2 years ]
    Neurological deterioration or death associated with intracerebral haemorrhage found on CT scan, MRI, or autopsy.


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 2 years ]
    Modified Rankin Scale score

  2. Death of any cause [ Time Frame: 2 years ]
    Death of any cause

  3. Vascular death [ Time Frame: 2 years ]
    Death of vascular cause

  4. Symptomatic epidural, subdural, or subarachnoid haemorrhage [ Time Frame: 2 years ]
    Neurological deterioration or death associated with epidural, subdural, or subarachnoid haemorrhage found on CT scan, MRI, or autopsy.

  5. Symptomatic major extracranial haemorrhage [ Time Frame: 2 years ]

    Clinically overt bleeding associated with one or more of:

    • Transfusion of >2 red cell units of blood
    • A fall in haemoglobin of 2 g/dL, (1.24 mmol/L)
    • Bleeding into retroperitoneum, intraocular space or major joint
    • Bleeding leading to permanent treatment cessation

  6. Ischaemic events [ Time Frame: 2 years ]
    Transient ischaemic attack, ischaemic stroke, unstable angina, acute myocardial infarction (type 1), peripheral arterial occlusion, mesenteric ischaemia, retinal arterial occlusion, deep vein thrombosis or pulmonary embolism.

  7. Cognitive outcome at two years [ Time Frame: 2 years ]
    Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age ≥18 years.
  • Spontaneous, primary ICH, of ≥1 day, but not more than 180 days after onset of qualifying ICH, i.e.:

    • No preceding traumatic brain injury, based on history from the patient/witness of spontaneous symptom onset, and brain imaging appearances consistent of spontaneous ICH (i.e. any brain/bone/soft tissue appearances of trauma must have occurred secondary to a spontaneous ICH)
    • No 'secondary' or underlying structural cause (e.g. haemorrhagic transformation of an ischaemic stroke, aneurysm, tumour, arteriovenous malformation, or intracerebral venous thrombosis)
  • Patient have indication for antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of ischaemic events, either antiplatelet drugs (for patients with vascular disease), or anticoagulant drug for patients with atrial fibrillation.
  • Consent to randomisation from the patient (or personal / legal / professional representative if the patient does not have mental capacity).
  • MRI (or CT) is performed before randomisation.

Exclusion Criteria:

  • Clear indication for antiplatelet or anticoagulant treatment (e.g. prosthetic heart valves).
  • Contraindications to the antithrombotic drug that will be administered.
  • Patient is pregnant, breastfeeding, or of childbearing age and not taking contraception.
  • For patients examined with MRI: Contraindication for brain MRI
  • Malignancy with life expectancy less than 2 years

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): NCT03186729


Contacts
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Contact: Eivind Berge, PhD 004722119100 eivind.berge@medisin.uio.no

Locations
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Denmark
Herlev Gentofte Hospital Recruiting
Copenhagen, Denmark, DK-2730
Contact: Christina Rostrup Kruuse, PhD       christina.kruuse@regionh.dk   
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Eivind Berge, PhD    004722118080    eivind.berge@medisin.uio.no   
Contact: Kristin Tveitan Larsen, MD    004798671138    k.t.larsen@medisin.uio.no   
Sweden
Umeå University Hospital Recruiting
Umeå, Sweden, SE-90185
Contact: Eva-Lotta Glader, PhD       eva-lotta.glader@umu.se   
Contact: Johanna Pennlert, PhD       johanna.pennlert@umu.se   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Eivind Berge, PhD Oslo University Hospital

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Responsible Party: Eivind Berge, Senior consultant and professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03186729     History of Changes
Other Study ID Numbers: Version/date 180315
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared within the COCROACH Collaboration.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Eivind Berge, Oslo University Hospital:
Intracerebral hemorrhage

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Atrial Fibrillation
Hemorrhage
Cerebral Hemorrhage
Intracranial Hemorrhages
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action