Study of Antithrombotic Treatment After IntraCerebral Haemorrhage

NCT03186729 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: Version/date 180315
• Study Type: interventional
• Target: 134
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Keywords

Intracerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• Fatal or non-fatal symptomatic ICH.

  Neurological deterioration or death associated with intracerebral haemorrhage found on CT scan, MRI, or autopsy.

  2 years

Secondary Outcomes (6)

• Functional outcome

  2 years

• Death of any cause

  2 years

• Vascular death

  2 years

• Symptomatic epidural, subdural, or subarachnoid haemorrhage

  2 years

• Symptomatic major extracranial haemorrhage

  2 years

Study Arms (2)

Antithrombotic treatment

EXPERIMENTAL

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

No antithrombotic treatment

NO INTERVENTION

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

Interventions

Antithrombotic Agent DRUG

Anticoagulant or antiplatelet drugs

Antithrombotic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (3)

Herlev Gentofte Hospital

Copenhagen, DK-2730, Denmark

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Umeå University Hospital

Umeå, SE-90185, Sweden

Location

Related Publications (2)

• Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2.

  PMID: 34022170 DERIVED

• Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7. No abstract available.

  PMID: 34022160 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Atrial Fibrillation

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Officials

• Torgeir Bruun Wyller, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader

Model Details: Randomised-controlled trial, parallel groups

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: July 1, 2018
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); NO (1); SE (1)