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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 2, 2020
Sponsor:
Information provided by (Responsible Party):
Torgeir Bruun Wyller, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE June 8, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • Functional outcome [ Time Frame: 2 years ]
    Modified Rankin Scale score
  • Death of any cause [ Time Frame: 2 years ]
    Death of any cause
  • Vascular death [ Time Frame: 2 years ]
    Death of vascular cause
  • 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.
  • 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
  • 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.
  • Cognitive outcome at two years [ Time Frame: 2 years ]
    Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
Official Title  ICMJE Study of Antithrombotic Treatment After IntraCerebral Haemorrhage
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised-controlled trial, parallel groups
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cerebral Hemorrhage
  • Intracranial Hemorrhages
  • Atrial Fibrillation
  • Anticoagulant-Induced Bleeding
  • Secondary Prevention
Intervention  ICMJE Drug: Antithrombotic Agent
Anticoagulant or antiplatelet drugs
Study Arms  ICMJE
  • 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
    Intervention: Drug: Antithrombotic Agent
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2031
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Torgeir Bruun Wyller, PhD 004791166682 t.b.wyller@medisin.uio.no
Listed Location Countries  ICMJE Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03186729
Other Study ID Numbers  ICMJE Version/date 180315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD will be shared within the COCROACH Collaboration.
Responsible Party Torgeir Bruun Wyller, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Torgeir Bruun Wyller, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP