EUCTR2009-017454-12-DE
Active, not recruiting
Not Applicable
INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOLA phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset. - IMS III
niversity of Cincinnati - Academic Medical Center -Department of Neurology0 sites900 target enrollmentNovember 9, 2010
ConditionsIschemic StrokeMedDRA version: 14.0Level: PTClassification code 10065528Term: NIH stroke scale score increasedSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.0Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsActilyse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- niversity of Cincinnati - Academic Medical Center -Department of Neurology
- Enrollment
- 900
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 through 82 years (i.e., candidates must have had their 18PthP birthday, but not had their 83rd birthday).
- •Initiation of IV rt\-PA within 3 hours of onset of stroke symptoms. Time of onset is defined as the last time when the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep).
- •An NIHSSS \= 10 at the time that IV rt\-PA is begun or an NIHSSS \>7 and \<10 with an occlusion seen in M1, ICA or basilar artery on CTA at institutions where baseline CTA imaging is standard of care for acute stroke patients.
- •Investigator verification that the subject has received/ is receiving the correct IV rt\-PA dose for the estimated weight prior to randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 300
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 600
Exclusion Criteria
- •History of stroke in the past 3 months.
- •Previous intra\-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation.
- •Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
- •Hypertension at time of treatment; systolic BP \> 185 or diastolic \> 110 mm Hg; or aggressive measures to lower blood pressure to below these limits are needed.
- •Presumed septic embolus, or suspicion of bacterial endocarditis
- •Presumed pericarditis including pericarditis after acute myocardial infarction.
- •Suspicion of aortic dissection
- •Recent (within 30 days) surgery or biopsy of parenchymal organ.
- •Recent (within 30 days) trauma, with internal injuries or ulcerative wounds.
- •Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.
Outcomes
Primary Outcomes
Not specified
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