Acute Ischemic StrokePhase 1/2NCT00507806
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
A Phase 1/2 study testing perflutren lipid microsphere in people with Acute Ischemic Stroke, run by ImaRx Therapeutics.
Trial summary
The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- perflutren lipid microsphere
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
- tPA eligible
- Occlusion of the middle cerebral artery
Who cannot join
- Right to left cardiac shunt
- Uncontrolled hypertension
- Absent temporal windows
About this study
The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- perflutren lipid microsphere
- Keywords
- Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perflutren lipid microsphereDrug
Also called Definity
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic intracranial hemorrhage
Measured: 72 hours
Secondary outcomes (3)
Complete recanalization of the occluded artery (TIBI 4-5)
Measured: End of treatment
NIHSS score of 0-2
Measured: 24 hours
Favorable outcome (modified Rankin Scale or NIHSS 0-1)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startMar 2005
- Study completionMay 2006
Why it stopped: for administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- ImaRx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrei Alexandrov, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507806
- Sponsor's protocol ID
- MRX-815-401
- Status last verified
- Jul 2007
- First submitted
- 25 Jul 2007
- Last updated
- 27 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. doi: 10.1056/NEJMoa041175.
PubMed 15548777
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00507806
- Acronym / sponsor ID
- MRX-815-401
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for administrative reasons
- Lead sponsor
- ImaRx TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2006 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
- tPA eligible
- Occlusion of the middle cerebral artery
Key exclusion criteria (3 listed)
- Right to left cardiac shunt
- Uncontrolled hypertension
- Absent temporal windows
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perflutren lipid microsphereAlso: Definity | Drug | – |
Primary outcome
Incidence of symptomatic intracranial hemorrhage
Time frame: 72 hours
3 secondary outcomes
Complete recanalization of the occluded artery (TIBI 4-5)
Time frame: End of treatment
NIHSS score of 0-2
Time frame: 24 hours
Favorable outcome (modified Rankin Scale or NIHSS 0-1)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: for administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2007.
- Background: PubMed 15548777Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. doi: 10.1056/NEJMoa041175.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Alexandrov, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing perflutren lipid microsphere in people with Acute Ischemic Stroke, run by ImaRx Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: for administrative reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic intracranial hemorrhage (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00507806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2007.