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.
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

April 2, 2010
July 11, 2013
May 2013
February 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01098981 on ClinicalTrials.gov Archive Site
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.
Symptomatic intracerebral hemorrhage [ Time Frame: 0-36 hours from treatment ] [ Designated as safety issue: Yes ]
The secondary outcome is a comparison of the rates of symptomatic intracerebral hemorrhage within 0-36 hours from initiation of treatment.
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • 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
  • 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
  • Experimental: Target group
    A combined treatment with transcranial US and systemic tPA
    Intervention: Device: Transcranial ultrasound as an adjunctive therapy to tPA
  • Active Comparator: Control group
    Systemic tPA alone
    Intervention: Drug: Standard of care tPA therapy for acute ischemic stroke
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
830
May 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Patrick Bobbitt, PhD +41 (0)44 550 0005 pbobbitt@cerevast.com
Contact: Jenny Pleas, MS (425) 821-1603 ext 8621 jpleas@cerevast.com
United States
 
NCT01098981
CEREVAST THERAPEUTICS CP-01
Yes
Cerevast Therapeutics, Inc.
Cerevast Therapeutics, Inc.
Not Provided
Principal Investigator: Andrei Alexandrov, MD CP-01 Global PI, University of Alabama, Birmingham, AL
Cerevast Therapeutics, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP