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Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

Primary Purpose

Stroke of Basilar Artery, Optical Coherence Tomography, Antithrombotics

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Unfractionated heparin

Acetylsalicylic Acid (ASA)

About this trial

This is an interventional treatment trial for Stroke of Basilar Artery focused on measuring Basilar, Stroke, Thrombus, Optical Coherence Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Sites / Locations

Sunnybrook Heath Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Optical coherence tomography confirmed residual thrombus

Optical coherence tomography confirmed no residual thrombus

Arm Description

Early antithrombotics

Best medical management

Outcomes

Primary Outcome Measures

Favorable outcome

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

Secondary Outcome Measures

Symptomatic Intracranial Hemorrhage

Incidence of residual thrombus

Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography

Excellent Outcome

Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.

Full Information

NCT ID

NCT04121611

First Posted

October 8, 2019

Last Updated

October 14, 2019

Sponsor

Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT04121611

Brief Title

Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

Official Title

Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

October 14, 2021 (Anticipated)

Study Completion Date

December 14, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke of Basilar Artery, Optical Coherence Tomography, Antithrombotics, Endovascular Thrombectomy

Keywords

Basilar, Stroke, Thrombus, Optical Coherence Tomography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Optical coherence tomography confirmed residual thrombus

Arm Type

Experimental

Arm Description

Early antithrombotics

Arm Title

Optical coherence tomography confirmed no residual thrombus

Arm Type

No Intervention

Arm Description

Best medical management

Intervention Type

Drug

Intervention Name(s)

Unfractionated heparin

Intervention Description

Intravenous unfractionated heparin (UFH) infusion within 6 hours of EVT with target activated partial thromboplastin time (aPTT) 64-86 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)

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic Acid (ASA)

Intervention Description

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

Primary Outcome Measure Information:

Title

Favorable outcome

Description

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

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Symptomatic Intracranial Hemorrhage

Time Frame

24 hours CT imaging ± 8 hours.

Title

Incidence of residual thrombus

Description

Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography

Time Frame

Immediately after endovascular thrombectomy

Title

Excellent Outcome

Description

Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christopher R Pasarikovski, MD

Phone

647-550-0862

chris.pasarikovski@mail.utoronto.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Victor XD Yang, MD

Phone

416-480-6100

Ext

87576

victor.yang@sunnybrook.ca

Facility Information:

Facility Name

Sunnybrook Heath Sciences Center

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher R Pasarikovski, MD

Phone

6475500862

chris.pasarikovski@mail.utoronto.ca

12. IPD Sharing Statement

Citations:

PubMed Identifier

31443067

Citation

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 23:1-6. doi: 10.3171/2019.5.JNS191252. Online ahead of print.

Results Reference

background

PubMed Identifier

29367334

Citation

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. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:

Results Reference

background

PubMed Identifier

19577962

Citation

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.

Results Reference

background

PubMed Identifier

27521435

Citation

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.

Results Reference

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Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

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