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

NCT04121611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-10-17

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2021-10-14
Completion
2021-12-14

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04121611 on ClinicalTrials.gov