Study of Antithrombotic Treatment After IntraCerebral Haemorrhage (STATICH)
|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: NCT03186729|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Hemorrhage Intracranial Hemorrhages Atrial Fibrillation Anticoagulant-Induced Bleeding Secondary Prevention||Drug: Antithrombotic Agent||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised-controlled trial, parallel groups|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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)
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
|Contact: Eivind Berge, PhDfirstname.lastname@example.org|
|Herlev Gentofte Hospital||Recruiting|
|Copenhagen, Denmark, DK-2730|
|Contact: Christina Rostrup Kruuse, PhD email@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0424|
|Contact: Eivind Berge, PhD 004722118080 firstname.lastname@example.org|
|Contact: Kristin Tveitan Larsen, MD 004798671138 email@example.com|
|Umeå University Hospital||Recruiting|
|Umeå, Sweden, SE-90185|
|Contact: Eva-Lotta Glader, PhD firstname.lastname@example.org|
|Contact: Johanna Pennlert, PhD email@example.com|
|Principal Investigator:||Eivind Berge, PhD||Oslo University Hospital|