Cerebrovascular AccidentPhase 2NCT00039832
ReoPro and Retavase to Restore Brain Blood Flow After Stroke
A Phase 2 study testing Abciximab (ReoPro) and Reteplase (Retavase) in people with Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 4 sites in 2 countries.
Trial summary
This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Abciximab (ReoPro) and Reteplase (Retavase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2002to May 2008
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be enrolled in the study only if they meet all of the following criteria:
- Diagnosis of acute ischemic stroke with onset between 3 and 24 hours prior to planned start of study drugs. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia, and not otherwise attributable to ICH or another disease process. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 24 hours are not eligible if their first symptoms started more than 24 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be intact. A careful history is important to determine when the patient was last without the presenting deficits.
- Disabling neurological deficit attributable to the acute stroke at the start of study drugs.
- NIHSS less than or equal to 16.
- Evidence on PWI MRI of a perfusion defect corresponding to the acute stroke syndrome of at least 2cm in diameter in both long and short axis in any slice. The PWI will be assessed by relative mean transit time (MTT) images. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion defect is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal DWI are eligible.
- Age 18 - 80 years, inclusive.
Who cannot join
- Patients will be excluded from the study for any of the following reasons:
- General:
- Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial.
- Time interval since stroke onset of less than 24 hours impossible to determine with high degree of confidence.
- Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
- Evidence of acute myocardial infarction defined as having at least two of the following three features: 1.) Chest pain suggestive of cardiac ischemia; 2.) EKG findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3.) Elevated troponin I
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- Contraindication to MRI scan.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- Patients who would refuse blood transfusions if medically indicated.
- Stroke Related:
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
- High clinical suspicion of septic embolus.
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- Baseline NIHSS greater than 16.
- MRI/CT Related:
- Evidence of acute or chronic ICH by head CT or MRI.
- Evidence of microbleed on gradient echo MRI (GRE).
- CT or MRI evidence of non-vascular cause for the neurological symptoms.
- Signs of mass effect causing shift of midline structures.
- Incomplete or uninterpretable DWI and PWI.
- DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment.
- Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke (this is evidence of a new ischemic lesion possibly greater than 24 hours in duration).
- Safety Related:
- Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
- Anticipated need for major surgery within 72 hours after start of study drugs, e.g., carotid endarterectomy, hip fracture repair.
- Any intracranial surgery, serious head trauma (any head injury that required hospitalization), within the past 3 months.
- Stroke within the past 3 months.
- History of ICH at any time in the past.
- Major trauma at the time of stroke, e.g., hip fracture.
- Blood glucose greater than 200 mg/dl.
- Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
- Intracranial aneurysm, unless surgically treated greater than 3 months.
- Major hemorrhage in past 21 days.
- Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures include but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplant. For non-listed procedures, the operating surgeon should be consulted to assess the risk.
- Presumed or documented history of vasculitis.
- Known systemic bleeding disorder, e.g., von Willebrand's disease, hemophilia, others.
- Platelet count less than 100,000 cells/microL.
- Congenital or acquired coagulopathy (e.g. secondary to anticoagulants causing either of the following:
- Activated partial thromboplastin time (aPPT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor XII deficiency. Protamine sulfate reversal of heparin effect does not alleviate this criterion.
- INR greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours.
- Potentially Interfering with Outcome Assessment:
- Life expectancy less than 3 months.
- Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or a complex disease that may confound treatment assessment.
- Serum creatinine, AST or ALT greater than 3 times the upper limit of normal for the local laboratory.
- Drug Related:
- Treatment of the qualifying stroke with any thrombolytic or GPIIbIIIa inhibitor outside of this protocol.
- Any administration of a thrombolytic drug in the prior 7 days.
- Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation.
- Treatment of the qualifying stroke with a low molecular weight heparinoid.
- Previous administration of abciximab, if known.
- Known allergy to murine proteins.
- Anticoagulation (evidenced by PT, PTT, or platelet count) caused by herbal therapy.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Suburban Hospital
Bethesda, Maryland, 20814
Washington Adventist Hospital
Takoma Park, Maryland
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: ReoPro Retavase Reperfusion of Stroke Safety Study - Imaging Evaluation
This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain).
The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset.
Read more
Patients between 18 and 80 years of age who have experienced 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 physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation).
All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study.
CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.
Read the detailed description
Objectives: This is a clinical trial to determine an acceptable dose of reteplase in combination with a fixed dose of abciximab for ischemic stroke 3-24 hours from onset.
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, acute ischemic stroke of moderate severity (NIH Stroke Scale less than or equal to 16 and lesion volume on diffusion MRI less than approximately one third of the volume of the middle cerebral artery territory), positive MRI evidence of hypoperfusion corresponding to the acute stroke symptoms, no MRI evidence of chronic micro-hemorrhages, and no other clinical, radiological or laboratory features associated with 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: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 microgram/kg/minute infusion (to a maximum of 10.0 microgram/minute) for 12 hours. The five dosing groups for the reteplase dose are 0 U, 2.5 U, 5.0 U, 7.5 U, and 10.0 U. A maximum of 72 patients will be treated using an adaptive statistical design, in which data on both the response and toxicity will be used to determine the dose for subsequent patients, thereby minimizing exposure to either ineffective or toxic doses. Non-investigational 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 reperfusion by MRI 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 treated 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Abciximab (ReoPro) and Reteplase (Retavase)
- Keywords
- Stroke, Abciximab, Reteplase, MRI, Cerebral Blood Flow
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abciximab (ReoPro) and Reteplase (Retavase)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CT Receives: Drug: Abciximab (ReoPro) and Reteplase (Retavase) |
| 2 | Experimental | MRI Receives: Drug: Abciximab (ReoPro) and Reteplase (Retavase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of symptomatic ICH, major systemic hemorrhage, or other serious adverse event, including death, within 48 hrs from start of study drug.
Measured: 30 days
Secondary outcomes (1)
All ICH types (fatal, symptomatic, asymptomatic), all bleeding (major, minor, insignificant), deaths, all serious adverse events (by subtype) at the 48 hours, 5 days, and 30 days tabulated by dose group and overall.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2002 (estimated)
- Study startMar 2002
- Primary completionApr 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039832
- Sponsor's protocol ID
- 020154
- Other IDs
- 02-N-0154
- Status last verified
- Sep 2011
- First submitted
- 12 Jun 2002
- Last updated
- 21 Sep 2011
- Results posted
- No
Publications
National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
PubMed 7477192Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
PubMed 10591382Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998 Oct 17;352(9136):1245-51. doi: 10.1016/s0140-6736(98)08020-9.
PubMed 9788453
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReoPro Retavase Reperfusion of Stroke Safety Study - Imaging Evaluation
- ClinicalTrials.gov ID
- NCT00039832
- Acronym / sponsor ID
- 020154
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke, Abciximab, Reteplase, MRI, Cerebral Blood Flow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Mar 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Jun 2002 (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.
This study will evaluate the safety and effectiveness of two types of blood thinners, abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after ischemic stroke (stroke resulting from a blood clot in the brain).
The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of onset of the stroke and most patients do not get to the hospital early enough to benefit from it. There is thus a pressing need to develop effective stroke treatments that can be initiated more than 3 hours after onset.
Patients between 18 and 80 years of age who have experienced 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 physical examination, blood tests and a magnetic resonance imaging (MRI) scan (if an MRI was not done during the stroke evaluation).
All participants will receive ReoPro. Some will also receive Retavase, which may boost the effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be monitored with physical examinations, blood tests, computed tomography (CT) scans, and three or four MRI scans of the brain to evaluate both the response to treatment and side effects of the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study medication, and possibly during screening for this study.
CT involves the use of specialized x-rays to obtain images of the brain. The patient lies still in the scanner for a short time while the X-ray images are formed. MRI uses a strong magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a medicine called gadolinium contrast is injected in a vein. This medicine brightens the images, creating better pictures of the blood flow.
Detailed description
Objectives: This is a clinical trial to determine an acceptable dose of reteplase in combination with a fixed dose of abciximab for ischemic stroke 3-24 hours from onset.
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, acute ischemic stroke of moderate severity (NIH Stroke Scale less than or equal to 16 and lesion volume on diffusion MRI less than approximately one third of the volume of the middle cerebral artery territory), positive MRI evidence of hypoperfusion corresponding to the acute stroke symptoms, no MRI evidence of chronic micro-hemorrhages, and no other clinical, radiological or laboratory features associated with 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: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 microgram/kg/minute infusion (to a maximum of 10.0 microgram/minute) for 12 hours. The five dosing groups for the reteplase dose are 0 U, 2.5 U, 5.0 U, 7.5 U, and 10.0 U. A maximum of 72 patients will be treated using an adaptive statistical design, in which data on both the response and toxicity will be used to determine the dose for subsequent patients, thereby minimizing exposure to either ineffective or toxic doses. Non-investigational 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 reperfusion by MRI 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 treated 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 design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Abciximab (ReoPro) and Reteplase (Retavase)CT |
| 2 | Experimental | Drug: Abciximab (ReoPro) and Reteplase (Retavase)MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of acute ischemic stroke with onset between 3 and 24 hours prior to planned start of study drugs. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia, and not otherwise attributable to ICH or another disease process. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. Patients whose deficits have worsened in the last 24 hours are not eligible if their first symptoms started more than 24 hours before. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be intact. A careful history is important to determine when the patient was last without the presenting deficits.
- Disabling neurological deficit attributable to the acute stroke at the start of study drugs.
- NIHSS less than or equal to 16.
- Evidence on PWI MRI of a perfusion defect corresponding to the acute stroke syndrome of at least 2cm in diameter in both long and short axis in any slice. The PWI will be assessed by relative mean transit time (MTT) images. The MRI evaluation must involve echo planar diffusion weighted imaging, MRA, and MRI perfusion. A normal appearing MRA with an appropriate perfusion defect is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal DWI are eligible.
- Age 18 - 80 years, inclusive.
Key exclusion criteria (52 listed)
- Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial.
- Time interval since stroke onset of less than 24 hours impossible to determine with high degree of confidence.
- Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
- Evidence of acute myocardial infarction defined as having at least two of the following three features: 1.) Chest pain suggestive of cardiac ischemia; 2.) EKG findings of ST elevation of greater than 0.2 mV in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3.) Elevated troponin I
- Contraindication to MRI scan.
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 |
|---|---|---|
| Abciximab (ReoPro) and Reteplase (Retavase) | Drug | 1, 2 |
Primary outcome
Occurrence of symptomatic ICH, major systemic hemorrhage, or other serious adverse event, including death, within 48 hrs from start of study drug.
Time frame: 30 days
1 secondary outcome
All ICH types (fatal, symptomatic, asymptomatic), all bleeding (major, minor, insignificant), deaths, all serious adverse events (by subtype) at the 48 hours, 5 days, and 30 days tabulated by dose group and overall.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Background: PubMed 7477192National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
- Background: PubMed 10591382Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, Pessin M, Ahuja A, Callahan F, Clark WM, Silver F, Rivera F. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in Acute Cerebral Thromboembolism. JAMA. 1999 Dec 1;282(21):2003-11. doi: 10.1001/jama.282.21.2003.
- Background: PubMed 9788453Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998 Oct 17;352(9136):1245-51. doi: 10.1016/s0140-6736(98)08020-9.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abciximab (ReoPro) and Reteplase (Retavase) in people with Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 4 sites in 2 countries.
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 6 inclusion and 52 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: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of symptomatic ICH, major systemic hemorrhage, or other serious adverse event, including death, within 48 hrs from start of study drug. (time frame: 30 days). 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 NCT00039832, which also lists 3 linked publications.
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 21 Sep 2011.