Clinical trial NCT04121611: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke of Basilar Artery
Optical Coherence Tomography
Antithrombotics
Endovascular Thrombectomy
Keywords: Basilar
Stroke
Thrombus
Optical Coherence Tomography
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Favorable outcome
timeFrame: 90 days
Secondary outcomes:
measure: Symptomatic Intracranial Hemorrhage
timeFrame: 24 hours CT imaging ± 8 hours.
measure: Incidence of residual thrombus
timeFrame: Immediately after endovascular thrombectomy
measure: Excellent Outcome
timeFrame: 90 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Heath Sciences Center
state: Ontario
Study officials:
References:
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;133(4):1141-1146. doi: 10.3171/2019.5.JNS191252. Print 2020 Oct 1.
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.
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.
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.