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

Optical Coherence Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121611
• Other study ID #: 1192019
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: December 14, 2021

Study information

• Verified date: October 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: Christopher R Pasarikovski, MD
• Phone: 647-550-0862
• Email: chris.pasarikovski[@]mail.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Heath Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. [Epub ahead of print] — View 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. Review. Erratum in: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable outcome	Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.	90 days
Secondary	Symptomatic Intracranial Hemorrhage		24 hours CT imaging ± 8 hours.
Secondary	Incidence of residual thrombus	Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography	Immediately after endovascular thrombectomy
Secondary	Excellent Outcome	Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.	90 days