ASP-II(Ancrod in Stroke Program-II):A Randomised, Double-Blind, Pacebo-Controlled Study of Ancrod(ViprinexTM IN Subjects Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke.
- Conditions
- Acute Ischemic Stroke
- Registration Number
- EUCTR2005-006067-31-AT
- Lead Sponsor
- eurobiological Technologies Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
1. Sudden onset of an ischemia-related neurological deficit involving the carotid, vertebrobasilar, or cerebral artery territories.
2. Diagnosis of stroke based on a physical examination conducted by a neurologist (defined as a physician with at least two years of specialty training in neurology) and included in the center's Form FDA 1572. (A stroke diagnosis made by a non-neurologist physician included in the center’s Form FDA 1572 will be accepted if the sponsor approves this physician’s qualifications and experience for diagnosing stroke in advance. Otherwise, the diagnosis must be confirmed by a neurologist within 24 hours of subject enrollment.)
3. Administration of ancrod is to begin within 6 hours (0-360 min) of the recognized onset of stroke symptoms; symptoms must last longer than 30 minutes, must not have significantly improved, and must be distinguished from an episode of generalized ischemia (e.g., syncope), active seizure, or migraine disorder. To insure that deficits beginning during sleep had not been present for more than 6 hours, such subjects must have been observed to be deficit-free within 6 hours before the time treatment is to begin.
4. No conditions other than stroke to which the subject's sudden clinical deterioration could have been attributed (e.g., pneumonia, systemic febrile infection), or which might interfere with the neurological evaluation (e.g., ipsilateral focal neurological deficits from old brain lesions, demyelinating disease, superimposed encephalopathy, or multi-infarct dementia).
5. Adult subjects (at least 18-years old).
6. Men or women, but women must not be pregnant or lactating; women of child-bearing potential must have a negative pregnancy test before receiving Viprinex™.
7. Baseline NIH Stroke Scale score of 5-25 to identify subjects with moderate-severe strokes.
8. Prestroke mRS = 2 to exclude subjects with relatively severe prestroke disability.
9. Written consent by the subject (or his/her representative if the subject is unable to sign personally) obtained and noted in the subject's chart.
Are the trial subjects under 18?
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Clinical or CT evidence of intracranial extravascular blood (e.g., cerebral hemorrhage, hemorrhagic infarction, subdural hematoma) or potentially progressive intracranial lesion (e.g., neoplasm, abscess) on head CT scan taken before treatment. CT evidence of the index ischemic stroke will not exclude subjects, but investigators should be fully satisfied that they have determined the time of symptom onset if there is extensive change related to the index stroke (e.g., hypodensity or obliteration of the gray/white junction exceeding 33% of the putative MCA distribution).
2. Stroke known or strongly suspected to be caused by an arterial dissection.
3. Unconscious or comatose state.
4. Seizures at or since onset of neurological deficit (in an effort to exclude subjects whose deficits are caused by Todd’s paralysis”). Seizures after study entry do not warrant discontinuation of study drug or termination of observations.
5. Stroke (ischemic or hemorrhagic) within the previous 6 weeks.
6. Improvement in the clinical deficit suggesting a resolving TIA based, for example, on documented improvement in NIHSS of = 3 points in the 30 min prior to beginning study drug, undocumented clinical observations, or other evidence of rapid clinical improvement.
7. Ipsilateral focal neurological deficits from prior lesions that would complicate subject evaluation.
8. Anticipated emergency surgery (including angioplasty) or general anesthesia within 5 days following start of the study medication infusion.
9. Recent (= 24 hours) or anticipated arterial puncture at a noncompressible site.
10. Current stroke occurring = 14 days after major surgery or = 30 days after carotid endarterectomy.
11. Hypertension, considered severe and uncontrolled by history or with serious complications, such as hypertensive encephalopathy at any time; or as detected on physical examination at Screening on the basis of a diastolic BP > 105 mmHg or systolic BP > 185 mmHg
12. Hypotension (systolic BP < 90 mm Hg).
13. Severe bradycardia (heart rate less than 40 beats/min at any time between stroke onset and treatment).
14. Baseline plasma fibrinogen level < 100 mg/dl.
Although the duration of the ancrod infusion depends on the pretreatment fibrinogen level, the protocol does not require that subject entry be stratified with respect to the fibrinogen level, and study drug treatment can be started before the pretreatment fibrinogen is reported. If a pretreatment plasma fibrinogen value < 100 mg/dL is reported after subject randomization, study drug infusion should be stopped.
15. Known disorder of platelet function or coagulation abnormality. Use of anticoagulants such as warfarin, heparin, low-molecular weight heparin or heparinoids, or abciximab (or similar antiplatelet agents) within 72 hours or planned use of an anticoagulant within 72 hours after beginning study medication.
Subjects who received warfarin or heparin but who are believed to be inadequately anticoagulated may be treated if their pretreatment INR is < 1.5 and if their pretreatment aPTT is = 45 sec or the local laboratory's upper limit of normal, whichever is higher.
16. Use of a thrombolytic agent (e.g., rt-PA, urokinase, streptokinase) within the prior 72 hours or planned use of a thrombolytic agent within 72 hours after beginning study drug. Thrombolytic agents should not have been used within the prior 72 hours to maintain patency of indwelling
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine whether ancrod (Viprinex™) begun intravenously within 6 hours after stroke onset confers statistically significant benefit in reducing the incidence of disability at 90 days. ;Secondary Objective: ;Primary end point(s): Reducing the incidence of disability at a day 90 after start of treatment
- Secondary Outcome Measures
Name Time Method