NCT04121611

Brief Summary

Evidence regarding the role of early (\<24 hours) antithrombotics post-revascularization with either intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), or a combination of both remains scarce. In 2018 the American Heart Association/American Stroke Association changed their recommendation, stating that the risk of antithrombotic therapy within the first 24 hours after treatment with IVT (with or without EVT) is uncertain. This was changed after data emerged that early antithrombotics may be safe and may improve outcomes in select patients undergoing EVT. Recently the investigators showed for the first time that significant residual basilar thrombus can exist after EVT despite complete angiographic revascularization using endovascular optical coherence tomography imaging. This residual thrombus could cause ongoing function-limiting strokes with occlusion of vital basilar perforators after EVT. Therefore, the investigators propose a prospective,non-randomized safety study to evaluate optical coherence tomography guided antithrombotic management for patients with confirmed residual thrombus after EVT for basilar occlusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 8, 2019

Last Update Submit

October 14, 2019

Conditions

Stroke of Basilar ArteryOptical Coherence TomographyAntithromboticsEndovascular Thrombectomy

Keywords

BasilarStrokeThrombusOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Favorable outcome

    Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

    90 days

Secondary Outcomes (3)

  • Symptomatic Intracranial Hemorrhage

    24 hours CT imaging ± 8 hours.

  • Incidence of residual thrombus

    Immediately after endovascular thrombectomy

  • Excellent Outcome

    90 days

Study Arms (2)

Optical coherence tomography confirmed residual thrombus

EXPERIMENTAL

Early antithrombotics

Drug: Unfractionated heparinDrug: Acetylsalicylic Acid (ASA)

Optical coherence tomography confirmed no residual thrombus

NO INTERVENTION

Best medical management

Interventions

Unfractionated heparinDRUG

1. Intravenous unfractionated heparin (UFH) infusion within 6 hours of EVT with target activated partial thromboplastin time (aPTT) 64-86 2. Anticoagulation to continue for minimum of 48 hours (can be maintained on UFH aPTT 64-86 or transitioned to low-molecular weight heparin (LMWH) Enoxaparin 1mg/kg)

Optical coherence tomography confirmed residual thrombus
Acetylsalicylic Acid (ASA)DRUG

1. Acetylsalicylic Acid (ASA) 325mg PO/PR/NG loading dose \< 2 hours of EVT completion 2. ASA 81mg PO OD maintenance dose

Optical coherence tomography confirmed residual thrombus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All patients deemed candidates for endovascular thrombectomy(EVT) for basilar artery occlusion. As no robust guidelines exist for the role of EVT in patients with acute basilar artery occlusion, the decision for EVT is made by a team of stroke neurologist and neuro-interventionalist at our regional stroke center.

You may not qualify if:

  • High-density lesion consistent with hemorrhage of any degree.
  • Significant established infarct size.
  • Contraindication to receiving post-revascularization antithrombotics for any reason (history of major hemorrhage in the past six months, hereditary or acquired bleeding diathesis, major surgery within last three months, platelets \<100 X 109 /L, coagulation factor deficiency, already on anticoagulant that would not allow administration of UFH)
  • Informed consent is not or cannot be obtained.
  • Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
  • Other serious, advanced, or terminal illness.
  • Patients who require hemodialysis or peritoneal dialysis.
  • Uncontrolled hypertension defined as systolic blood pressure\>185 mm Hg or diastolic blood pressure\>110mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Heath Sciences Center

Toronto, Ontario, M4N3M5, Canada

RECRUITING

Related Publications (4)

  • Pasarikovski CR, Ramjist J, da Costa L, Black SE, Yang V. Optical coherence tomography imaging after endovascular thrombectomy for basilar artery occlusion: report of 3 cases. J Neurosurg. 2019 Aug 23;133(4):1141-1146. doi: 10.3171/2019.5.JNS191252. Print 2020 Oct 1.

    PMID: 31443067BACKGROUND

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.

    PMID: 29367334BACKGROUND

  • Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.

    PMID: 19577962BACKGROUND

  • Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ, Lee SH. Stroke outcomes with use of antithrombotics within 24 hours after recanalization treatment. Neurology. 2016 Sep 6;87(10):996-1002. doi: 10.1212/WNL.0000000000003083. Epub 2016 Aug 12.

    PMID: 27521435BACKGROUND

MeSH Terms

Conditions

StrokeThrombosis

Interventions

HeparinAspirin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Christopher R Pasarikovski, MD

CONTACT

647-550-0862chris.pasarikovski@mail.utoronto.ca

Victor XD Yang, MD

CONTACT

416-480-6100victor.yang@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgeon

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

October 14, 2019

Primary Completion

October 14, 2021

Study Completion

December 14, 2021

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

CA(1)