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 (CLOTBUST-ER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Cerevast Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Cerevast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01098981
First received: April 2, 2010
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Device: Transcranial ultrasound as an adjunctive therapy to tPA
Drug: Standard of care tPA therapy for acute ischemic stroke
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization (CLOTBUST-ER) in Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Cerevast Therapeutics, Inc.:

Primary Outcome Measures:
  • Modified Rankin score 0-1 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to compare clinical recovery rates (modified Rankin score 0-1) at 3 months after stroke onset.


Secondary Outcome Measures:
  • Symptomatic intracerebral hemorrhage [ Time Frame: 0-24 hours from treatment ] [ Designated as safety issue: Yes ]
    The secondary outcome is a comparison of the rates of symptomatic intracerebral hemorrhage within 0-24 hours from initiation of treatment.


Estimated Enrollment: 830
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Target group
A combined treatment with transcranial US and systemic tPA
Device: Transcranial ultrasound as an adjunctive therapy to tPA
  • tPA per approved labeling administered over 60 minutes
  • Ultrasonic headframe with active insonation for 120 minutes
Active Comparator: Control group
Systemic tPA alone
Drug: Standard of care tPA therapy for acute ischemic stroke
  • tPA per approved labeling administered over 60 minutes
  • Ultrasonic headframe with sham (inactive) insonation for 120 minutes

Detailed Description:

The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score 0-1). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 4.5 hours from onset of symptoms
  3. No signs of intracranial bleeding on assessment by non-contrast CT
  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. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098981

Contacts
Contact: Patrick Bobbitt, PhD +41 (0)44 550 0005 pbobbitt@cerevast.com
Contact: Jenny Pleas, MS (425) 821-1603 ext 8621 jpleas@cerevast.com

Locations
United States, Washington
Cerevast Therapeutics, Inc. Recruiting
Redmond, Washington, United States, 98052-2431
Contact: Patrick Bobbitt    +41 (0)44 550 0005    pbobbitt@cerevast.com   
Contact: Jenny Pleas    (425)821-1603 ext 8621    jpleas@cerevast.com   
Sponsors and Collaborators
Cerevast Therapeutics, Inc.
Investigators
Principal Investigator: Andrei Alexandrov, MD CP-01 Global PI, University of Alabama, Birmingham, AL
  More Information

No publications provided

Responsible Party: Cerevast Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01098981     History of Changes
Other Study ID Numbers: CEREVAST THERAPEUTICS CP-01
Study First Received: April 2, 2010
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 28, 2014