Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061373
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2003-05-23
Brief Title:
Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial CATALIST
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial CATALIST
Status:
COMPLETED
Status Verified Date:
2012-12
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:
CATALIST
Brief Summary:
Ischemic stroke is caused by a blood clot that blocks the flow of blood to the brain and damages brain cells The clot or thrombus is made up of platelets and fibrin The medicine alteplase also known as tPA is the standard drug used to treat patients with acute ischemic stroke tPA attacks the fibrin portion of the blood clot While intravenous iv tPA alone is effective in treating the fibrin part of the clot approximately 30 of the time adding other commercially available drugs such eptifibatide to treat other clot components may improve the effectiveness of iv tPA therapy
This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin the low molecular weight heparin tinzaparin and standard iv tPA therapy for the treatment of acute ischemic stroke Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage Alsoselection and evaluation of patients by magnetic resonance imaging MRI criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose
This is a clinical trial to determine an acceptable dose of eptifibatide in combination with aspirin the low molecular weight heparin tinzaparin and standard iv tPA therapy for the treatment of acute ischemic stroke Use of clinical and imaging based selection criteria are hypothesized to contribute to treatment safety by selecting patients at lower risk of intracerebral hemorrhage Alsoselection and evaluation of patients by magnetic resonance imaging MRI criteria will result in a different risk to benefit ratio than selecting patients without MRI criteria and will lead to a different acceptable dose
Detailed Description:
Study Population All acute ischemic stroke patients treated with standard iv tPA therapy within 3 hours from stroke onset will be considered for study participation Patient will be selected by criteria to minimize likelihood of toxicity and maximize likelihood of response These criteria include age 18-85 years old acute ischemic stroke of moderate severity measured using the National Institutes of Health Stroke Scale Stroke Scale NIHSS less than 22 for left hemisphere strokes less than 17 for others and no other clinical radiological or laboratory features associated with increased risk of hemorrhage of thrombolytic therapy In the MRI arm of the trial patients must have positive MRI evidence of hypoperfusion corresponding to the acute stroke symptoms and no MRI evidence of chronic micro-hemorrhages
Design This is an open-label dose escalation safety and proof of principle clinical trial All patients will receive iv tPA therapy plus 81 mg aspirin orally or 150 mg rectally and 80 anti Xa IUkg tinzaparin subcutaneously and some patients will receive iv eptifibatide Intravenous eptifibatide will be given in a dose-escalating manner The five dosing groups for eptifibatide are 0 45 micro gkg bolus 90 micro gkg bolus 90 micro gkg bolus plus 025 micro gkgmin infusion for 24 hours and 90 mgkg bolus plus 05 micro gkgmin infusion for 24 hours Investigational therapy is to begin as early as possible but no later than 6 hours after the onset of the patients symptoms Two arms - an MRI and a non-MRI arm - will receive identical drug regimesand dose escalation will proceed independently in either arm
A maximum of 100 patients in each arm will be studied a minimum of 15 patients treated at each dose level The outcomes will be monitored by a Data and Safety Monitoring Board DSMB The DSMB will have the authority to stop or recommend modifications of the trial for safety concerns throughout the trial and after any occurrence of severe adverse events SAE Dose escalation from one dose level to the next will be contingent on DSMB approval
Outcome Measures The primary safety endpoint for determination of toxicity will be any one of the following symptomatic intracranial hemorrhage ICH major systemic hemorrhage or other SAE related to study drug administration within 72 hours from start of therapy Adverse events will be monitored for 30 days The primary efficacy endpoint for response in the MRI arm will be reperfusion as measured by perfusion weighted imaging PWI at both 2 hours and 24 hours after start of therapy and substantial clinical recovery at 24 hours for the non-MRI arm Clinical outcome variables and imaging variables will be recorded and analyzed in secondary and exploratory analyses If an acceptable dose of eptifibatide is identified that dose of eptifibatide will be investigated in a subsequent randomized placebo-controlled trial
MRI and CT are used as radiological measures of brain hemorrhage The NIH Stroke Scale NIHSS is used to measure neurological worsening or recovery
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness language neglect visual-field loss extra ocular movement motor strength ataxia dysarthria and sensory loss A trained observer rates the patients ability to answer questions and perform activities Ratings for each of the 15 items are scored Patients who have a score of 0 are considered to have normal examination Patients with a score of 40 have the most severe stroke symptoms
Design This is an open-label dose escalation safety and proof of principle clinical trial All patients will receive iv tPA therapy plus 81 mg aspirin orally or 150 mg rectally and 80 anti Xa IUkg tinzaparin subcutaneously and some patients will receive iv eptifibatide Intravenous eptifibatide will be given in a dose-escalating manner The five dosing groups for eptifibatide are 0 45 micro gkg bolus 90 micro gkg bolus 90 micro gkg bolus plus 025 micro gkgmin infusion for 24 hours and 90 mgkg bolus plus 05 micro gkgmin infusion for 24 hours Investigational therapy is to begin as early as possible but no later than 6 hours after the onset of the patients symptoms Two arms - an MRI and a non-MRI arm - will receive identical drug regimesand dose escalation will proceed independently in either arm
A maximum of 100 patients in each arm will be studied a minimum of 15 patients treated at each dose level The outcomes will be monitored by a Data and Safety Monitoring Board DSMB The DSMB will have the authority to stop or recommend modifications of the trial for safety concerns throughout the trial and after any occurrence of severe adverse events SAE Dose escalation from one dose level to the next will be contingent on DSMB approval
Outcome Measures The primary safety endpoint for determination of toxicity will be any one of the following symptomatic intracranial hemorrhage ICH major systemic hemorrhage or other SAE related to study drug administration within 72 hours from start of therapy Adverse events will be monitored for 30 days The primary efficacy endpoint for response in the MRI arm will be reperfusion as measured by perfusion weighted imaging PWI at both 2 hours and 24 hours after start of therapy and substantial clinical recovery at 24 hours for the non-MRI arm Clinical outcome variables and imaging variables will be recorded and analyzed in secondary and exploratory analyses If an acceptable dose of eptifibatide is identified that dose of eptifibatide will be investigated in a subsequent randomized placebo-controlled trial
MRI and CT are used as radiological measures of brain hemorrhage The NIH Stroke Scale NIHSS is used to measure neurological worsening or recovery
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness language neglect visual-field loss extra ocular movement motor strength ataxia dysarthria and sensory loss A trained observer rates the patients ability to answer questions and perform activities Ratings for each of the 15 items are scored Patients who have a score of 0 are considered to have normal examination Patients with a score of 40 have the most severe stroke symptoms
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 |
|---|---|---|---|
| 03-N-0171 | None | None | None |