Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke

Overview

About this study

This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Males or females 18 - 80 years of age
  2. Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 0-3 hours from onset of symptoms
  3. No signs of intracranial bleeding on assessment by non-contrast CT or non-contrast MRI
  4. Subjects with neurological deficits of a total NIHSS score ≥ 10 points
  5. Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards
  6. SBP ≤ 185 mmHg and DBP ≤ 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
  7. Pre-morbid modified Rankin score of 0-1
  8. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations
  9. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations
  10. For subjects in the optional arterial recanalization substudy:
    1. Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions
    2. Measured glomerular filtration rate (GFR) ≥ 60 mL/min for patients undergoing CTA or MRA

Exclusion Criteria:

  1. Subjects with primary intra-arterial thrombolysis
  2. Females who are pregnant or breast feeding
  3. Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment
  4. Subjects with any standard contraindication for intravenous tPA therapy
  5. Significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study
  6. Participation in this study may exclude you from participating in other clinical trials

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Cumara O'Carroll, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions