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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2021-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke of Basilar Artery Optical Coherence Tomography Antithrombotics Endovascular Thrombectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optical coherence tomography confirmed residual thrombus

Early antithrombotics

Group Type EXPERIMENTAL

Unfractionated heparin

Intervention Type DRUG

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)

Acetylsalicylic Acid (ASA)

Intervention Type 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 no residual thrombus

Best medical management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Unfractionated heparin

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)

Intervention Type DRUG

Acetylsalicylic Acid (ASA)

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No