Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2024-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cerebral Hemorrhage Intracranial Hemorrhages Atrial Fibrillation Anticoagulant-Induced Bleeding Secondary Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised-controlled trial, parallel groups

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Antithrombotic Agent

Intervention Type DRUG

Anticoagulant or antiplatelet drugs

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antithrombotic Agent

Anticoagulant or antiplatelet drugs

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No