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

October 14, 2019 updated by: Dr. Victor Yang, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Optical coherence tomography confirmed residual thrombus
Early antithrombotics
Drug: 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)
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
NO_INTERVENTION: Optical coherence tomography confirmed no residual thrombus
Best medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorable outcome
Time Frame: 90 days
Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2019

Primary Completion (ANTICIPATED)

October 14, 2021

Study Completion (ANTICIPATED)

December 14, 2021

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1192019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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