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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121611
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Victor Yang, Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Stroke of Basilar Artery Optical Coherence Tomography Antithrombotics Endovascular Thrombectomy Drug: Unfractionated heparin Drug: Acetylsalicylic Acid (ASA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

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



Primary Outcome Measures :
  1. Favorable outcome [ Time Frame: 90 days ]
    Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.


Secondary Outcome Measures :
  1. Symptomatic Intracranial Hemorrhage [ Time Frame: 24 hours CT imaging ± 8 hours. ]
  2. 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

  3. Excellent Outcome [ Time Frame: 90 days ]
    Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121611


Contacts
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Contact: Christopher R Pasarikovski, MD 647-550-0862 chris.pasarikovski@mail.utoronto.ca
Contact: Victor XD Yang, MD 416-480-6100 ext 87576 victor.yang@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Heath Sciences Center Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Christopher R Pasarikovski, MD    6475500862    chris.pasarikovski@mail.utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Publications:

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Responsible Party: Dr. Victor Yang, Neurosurgeon, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04121611    
Other Study ID Numbers: 1192019
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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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
Keywords provided by Dr. Victor Yang, Sunnybrook Health Sciences Centre:
Basilar
Stroke
Thrombus
Optical Coherence Tomography
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics