NCT02998905

Brief Summary

To determine the feasibility of a controlled trial examining the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with ASA for stroke prevention in patients with a high-risk of atrial fibrillation and previous intracerebral hemorrhage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Apr 2017

Typical duration for phase_2 atrial-fibrillation

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

November 25, 2016

Last Update Submit

March 18, 2020

Conditions

Atrial FibrillationIntracerebral Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • Recruitment rate

    The mean number of patients randomized per site per year.

    Through study completion; ~ 30 months

  • Composite of ischemic stroke and recurrent intracerebral hemorrhage

    The composite of ischemic stroke and recurrent intracerebral hemorrhage

    Through study completion; average of 1 year

Secondary Outcomes (13)

  • Refusal rate

    Through study completion; average of 1 year

  • Retention rate

    Through study completion; average of 1 year

  • Ischemic stroke

    Through study completion; average of 1 year

  • Intracerebral hemorrhage

    Through study completion; average of 1 year

  • Fatal stroke

    Through study completion; average of 1 year

  • +8 more secondary outcomes

Other Outcomes (1)

  • Weighted net clinical benefit

    Through study completion; average of 1 year

Study Arms (2)

NOAC

EXPERIMENTAL

Apixaban or dabigatran or edoxaban or rivaroxaban

Drug: NOAC

Acetylsalicylic Acid

ACTIVE COMPARATOR

Acetylsalicylic acid

Drug: Acetylsalicylic Acid

Interventions

NOACDRUG

Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator.

NOAC
Acetylsalicylic AcidDRUG

Acetylsalicylic acid 81 mg/day

Acetylsalicylic Acid

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous primary intracerebral hemorrhage
  • Atrial fibrillation (CHADS2 ≥ 2)

You may not qualify if:

  • Non-stroke indication for antiplatelet or anticoagulant therapy
  • Recent intracerebral hemorrhage within 14 days
  • Platelet count less than 100,000/mm3 at enrollment or other bleeding diathesis
  • Prior symptomatic lobar intracerebral hemorrhage other than the qualifying event
  • Uncontrollable hypertension consistently above SBP/DBP of 160/100 mmHg
  • Known hypersensitivity to either ASA or NOACs
  • Inability to adhere to study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V6T 2B5, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L9G1J8, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.

    PMID: 36700520DERIVED

MeSH Terms

Conditions

Atrial FibrillationCerebral Hemorrhage

Interventions

N(4)-oleylcytosine arabinosideAspirin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesHemorrhage

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Ashkan Shoamanesh, MD FRCPC

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine (Neurology)

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 21, 2016

Study Start

April 26, 2017

Primary Completion

October 31, 2019

Study Completion

February 18, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(9)