Recruiting

Antithrombotic Treatment

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04121611

Conditions

Stroke of Basilar Artery

Optical Coherence Tomography

Antithrombotics

Endovascular Thrombectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Unfractionated heparin

Acetylsalicylic Acid (ASA)

Study Details

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.

Conditions

Stroke of Basilar Artery

Optical Coherence Tomography

Antithrombotics

Endovascular Thrombectomy

Study ID

NCT04121611

Start date

Oct 14, 2019

Status verified date

Oct, 2019

Completion date

Dec 14, 2021

Anticipated

Primary completion date

Oct 14, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Optical coherence tomography confirmed residual thrombus

Early antithrombotics

no intervention: Optical coherence tomography confirmed no residual thrombus

Best medical management

Interventions

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)

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

Primary outcome measure

  • Favorable outcome [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Christopher R Pasarikovski, MD

647-550-0862chris.pasarikovski@mail.utoronto.ca

Victor XD Yang, MD

416-480-6100victor.yang@sunnybrook.ca

Locations

Sunnybrook Heath Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Christopher R Pasarikovski, MD

6475500862chris.pasarikovski@mail.utoronto.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Oct 17, 2019

Last verified

Oct, 2019

Keywords

  • Basilar
  • Stroke
  • Thrombus
  • Optical Coherence Tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2019-10-17.