NCT04891861

Brief Summary

Randomized pilot trial of restarting DOACs at 1 week versus 4 weeks after traumatic intracranial hemorrhage

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2021

Status
unknown

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

May 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 10, 2021

Last Update Submit

May 14, 2021

Conditions

Anticoagulants; Increased

Keywords

restartanticoagulantDOAC

Outcome Measures

Primary Outcomes (1)

  • 60-day composite endpoint

    A 60-day composite endpoint that includes the following clinical events: New or expansion of intracranial hemorrhage, other BARC3a or above major hemorrhage 28, stroke, systemic embolism, myocardial infarction, proximal lower extremity deep vein thrombosis, pulmonary embolism and cardiovascular death

    60 days

Secondary Outcomes (3)

  • Disability Rating Scale (0-29 scale range)

    60 days

  • Modified Rankin Scale (0-6 scale range)

    60 day

  • Standard Gamble

    pre-randomization (The day before randomization, which must occur within 6 days of index injury) and after endpoints (the day after one of the endpoints occurs. We cannot know precisely when this will occur in the 60 day follow up period)

Study Arms (2)

1 week restart

ACTIVE COMPARATOR

restart DOAC at 1 week post injury at label dose and frequency

Drug: Apixaban

4 week restart

ACTIVE COMPARATOR

restart DOAC at 4 weeks post injury at label dose and frequency

Drug: Apixaban

Interventions

ApixabanDRUG

Direct Oral Anticoagulation all at label dose and frequency

Also known as: Rivaroxaban, Edoxaban, Dabigatran
1 week restart4 week restart

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute traumatic intracranial hemorrhage on anticoagulation for Atrial Fibrillation (AF) or Venous Thromboembolism (VTE)
  • Patient is higher risk for stroke or other thrombotic events as witnessed by having a CHA2DS2-VASc score of \> 3 (at least 3 of the following risk factors: age greater than 65, (age \> 75 counts for 2 points), history of stroke or TIA (2 points), history of heart failure, history of diabetes, history of atherosclerotic vascular disease, female biological sex, history of hypertension)
  • DOAC prescribed at label dose with creatinine clearance adjustments. DOAC at continuation dose, i.e., not initial therapy high doses in the setting of VTE

You may not qualify if:

  • Mechanical Valve or Ventricular Assist Device (VAD)
  • SDH \>8 mm maximum width or any midline shift at any time point or more than one SDH
  • Physician plan to start/restart antiplatelet therapy during trial period
  • Abbreviated Injury Scale other than head \>3
  • Pregnancy
  • Inability to understand need for adherence to study protocol
  • Any active pathological bleeding (e.g. no acute blood on most recent CT)
  • Hypersensitivity to drug or other label contraindication
  • Any bleeding that the investigator deems unsafe to restart DOAC at 1 week post injury, or conversely unsafe to hold DOAC to 4 weeks
  • Completion of DOAC therapy expected prior to 60 day primary endpoint, e.g. 3-6 month VTE treatment
  • Concomitant need for strong inducers/inhibitors of p-gp and CYP3A4
  • Low body weight (\<45kg)
  • Inability to swallow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Milling TJ Jr, Warach S, Johnston SC, Gajewski B, Costantini T, Price M, Wick J, Roward S, Mudaranthakam D, Dula AN, King B, Muddiman A, Lip GYH. Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage. J Neurotrauma. 2021 Jun 1;38(13):1791-1798. doi: 10.1089/neu.2020.7535. Epub 2021 Apr 6.

    PMID: 33470152RESULT

MeSH Terms

Interventions

apixabanRivaroxabanedoxabanDabigatran

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Truman J Milling, MD

CONTACT

5124969742tmilling@ascension.org

Steven Warach, MD PhD

CONTACT

steven.warach@austin.utexas.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Central blinded assessment of endpoints
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial of 1 versus 4 week DOAC restart after TICrH
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director SDMS Stroke Institute

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 19, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Sharing via BIOLINCC

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After primary publication