An interventional study of Unfractionated heparin and Acetylsalicylic Acid (ASA) in Stroke of Basilar Artery, Optical Coherence Tomography and Antithrombotics, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-17.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early antithrombotics
Drug: Unfractionated heparin · Drug: Acetylsalicylic Acid (ASA)
Best medical management
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)
1. Acetylsalicylic Acid (ASA) 325mg PO/PR/NG loading dose \< 2 hours of EVT completion 2. ASA 81mg PO OD maintenance dose
Favorable outcome
Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Time frame: 90 days
Symptomatic Intracranial Hemorrhage
Time frame: 24 hours CT imaging ± 8 hours.
Incidence of residual thrombus
Fraction of patients with residual thrombus after endovascular thrombectomy as observed with optical coherence tomography
Time frame: Immediately after endovascular thrombectomy
Excellent Outcome
Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
Time frame: 90 days
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre