Trial | NCT01098981  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    alteplase ...

  • Study Participants

    675
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 ordinal shift analysis). 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.
Study Started
May 31
2013
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Apr 07
2015
Estimate

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

Target group Experimental

A combined treatment with transcranial US and systemic tPA

Control group Active Comparator

Systemic tPA alone

Criteria 

Inclusion Criteria:

Males or females 18 - 80 years of age
Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms
No signs of intracranial bleeding on assessment by non-contrast CT
Subjects with neurological deficits of a total NIHSS score ≥ 10 points
Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards
SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
Pre-morbid modified Rankin score of 0-1
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
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

For subjects in the optional arterial recanalization substudy:

Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA or MRA

Exclusion Criteria:

Subjects with primary intra-arterial thrombolysis
Females who are pregnant or breast feeding
Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment
Subjects with any standard contraindication for intravenous tPA therapy
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
No Results Posted