Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046293
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-09-25
Brief Title:
ReoPro and Retavase to Treat Acute Stroke
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
ReoPro Retavase Reperfusion of Stroke Safety Study-Imaging Evaluation With Computed Tomography ROSIE-CT
Status:
COMPLETED
Status Verified Date:
2011-04-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the dose of Retavase that can safely be combined with ReoPro in treating acute ischemic stroke stroke resulting from a blood clot in the brain ReoPro and Retavase are currently approved by the Food and Drug Administration to treat heart problems caused by blockage of heart arteries The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA This treatment is effective only if begun within 3 hours of onset of the stroke however and most patients do not get to the hospital early enough to benefit from it
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke and a computed tomography CT scan of the head CT involves the use of specialized X-rays to obtain images of the brain The patient lies on a table that is moved into a cylindrical machine the scanner for the imaging study which usually takes about 5 to 10 minutes
All participants will receive 025 mgkg of ReoPro maximum dose of 30 mg The drug is infused into the vein over 12 hours Some patients will also receive one of four doses of Retavase which may boost the effectiveness of ReoPro in opening the blocked blood vessel Retavase is given through a needle in the vein over 2 minutes Patients will be monitored daily until discharge from the hospital or until day 5 whichever is earlier Assessments will include physical examinations blood tests to examine factors involved in blood clotting and CT scans to evaluate both the response to treatment and drug side effects They will return for a follow-up examination and CT scan 30 days after treatment
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between 3 and 24 hours before starting study drugs may be eligible for this study Candidates will be screened with a medical history and physical examination blood tests rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke and a computed tomography CT scan of the head CT involves the use of specialized X-rays to obtain images of the brain The patient lies on a table that is moved into a cylindrical machine the scanner for the imaging study which usually takes about 5 to 10 minutes
All participants will receive 025 mgkg of ReoPro maximum dose of 30 mg The drug is infused into the vein over 12 hours Some patients will also receive one of four doses of Retavase which may boost the effectiveness of ReoPro in opening the blocked blood vessel Retavase is given through a needle in the vein over 2 minutes Patients will be monitored daily until discharge from the hospital or until day 5 whichever is earlier Assessments will include physical examinations blood tests to examine factors involved in blood clotting and CT scans to evaluate both the response to treatment and drug side effects They will return for a follow-up examination and CT scan 30 days after treatment
Detailed Description:
Objectives This is the companion protocol to the ROSIE protocol This clinical trial will determine an acceptable dose of reteplase in combination with a fixed dose of abciximab for ischemic stroke 3-24 hours from onset in patients screened with brain CT rather than MRI as required by the ROSIE protocol The importance of this study relative to ROSIE will be its relevance to the large proportion of acute stroke patients who cannot have a screening MRI because of contraindications or unavailability of emergency MRI at their hospital
Study Population Patients will be selected by criteria to minimize likelihood of toxicity and maximize likelihood of response These criteria include age 18-80 years old patients who cannot get acute MRI because of contraindication to or unavailability of MRI acute ischemic stroke of moderate severity NIH Stroke Scale less than or equal to 16 and ischemic changes on CT scan less than approximately one third of the volume of the middle cerebral artery territory no evidence of hemorrhage on CT and no other clinical radiological or laboratory features associated with increased risk of hemorrhage with thrombolytic therapy
Design The study is open-label dose escalation safety and proof of principle study of the combination of intravenous abciximab and reteplase A fixed dose of abciximab will be used in all patients 025 mgkg bolus to a maximum of 30 mg followed by a 0125 microgramkgminute infusion to a maximum of 100 microgramminute for 12 hours The five dosing groups for the reteplase dose are 0U 25 U 50 U 75 U and 100 U A maximum of 72 patients will be treated using an adaptive statistical design Non-investigation patient management will be standardized across all patients according to the NIH Stroke Center Clinical Care Pathway
Outcome Measures The primary efficacy endpoint for response will be clinical improvement complete recovery or improvement of 4 points or more on the NIH Stroke Scale at 24 hours after start of therapy The primary safety endpoint for determination of toxicity will be any one of the following symptomatic intracranial hemorrhage ICH major systemic hemorrhage or other serious adverse event related to study drug administration including death within 48 hours from start of therapy The maximum acceptable rate of toxicity will be 10 of patients treated at any dose level and the minimum acceptable rate of response will be 50 of patients at any dose level The outcomes will be monitored by a Data and Safety Monitoring Committee which will have the authority to stop or recommend modifications of the trial for safety concerns Other clinical outcome variables and imaging variables will be recorded and analyzed in secondary and exploratory analyses If an acceptable dose is identified then that will be investigated in a subsequent randomized placebo-controlled trial
Study Population Patients will be selected by criteria to minimize likelihood of toxicity and maximize likelihood of response These criteria include age 18-80 years old patients who cannot get acute MRI because of contraindication to or unavailability of MRI acute ischemic stroke of moderate severity NIH Stroke Scale less than or equal to 16 and ischemic changes on CT scan less than approximately one third of the volume of the middle cerebral artery territory no evidence of hemorrhage on CT and no other clinical radiological or laboratory features associated with increased risk of hemorrhage with thrombolytic therapy
Design The study is open-label dose escalation safety and proof of principle study of the combination of intravenous abciximab and reteplase A fixed dose of abciximab will be used in all patients 025 mgkg bolus to a maximum of 30 mg followed by a 0125 microgramkgminute infusion to a maximum of 100 microgramminute for 12 hours The five dosing groups for the reteplase dose are 0U 25 U 50 U 75 U and 100 U A maximum of 72 patients will be treated using an adaptive statistical design Non-investigation patient management will be standardized across all patients according to the NIH Stroke Center Clinical Care Pathway
Outcome Measures The primary efficacy endpoint for response will be clinical improvement complete recovery or improvement of 4 points or more on the NIH Stroke Scale at 24 hours after start of therapy The primary safety endpoint for determination of toxicity will be any one of the following symptomatic intracranial hemorrhage ICH major systemic hemorrhage or other serious adverse event related to study drug administration including death within 48 hours from start of therapy The maximum acceptable rate of toxicity will be 10 of patients treated at any dose level and the minimum acceptable rate of response will be 50 of patients at any dose level The outcomes will be monitored by a Data and Safety Monitoring Committee which will have the authority to stop or recommend modifications of the trial for safety concerns Other clinical outcome variables and imaging variables will be recorded and analyzed in secondary and exploratory analyses If an acceptable dose is identified then that will be investigated in a subsequent randomized placebo-controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0301 | None | None | None |