Brain InfarctionPhase 3NCT00343174
Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms
A Phase 3 study testing Ancrod in people with Brain Infarction and Cerebral Ischemia, run by Heidelberg University.
Trial summary
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( < 15% in best clinical care institutions ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Infarction, Cerebral Ischemia, Acute Stroke
- What is being tested?
- Ancrod
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 18 years and above, both sexes
- Acute ischemic stroke with first symptoms within 6 hours of beginning
- Treatment after onset of symptoms
- SSS < 40 at baseline ( consciousness necessary )
Who cannot join
- Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation
- CT evidence of major signs of developing infarction
- Coma
- Prior strokes within 6 weeks
- Severe hypertension (> 220 systolic > 120 mm Hg diastolic)
- Baseline fibrinogen < 100 mg/dL
- Recent use of thrombolytic agents
- Recent or anticipated surgery
About this study
Official title: Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( < 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.
- Conditions
- Brain Infarction, Cerebral Ischemia, Acute Stroke
- Being tested
- Ancrod
- Keywords
- stroke, vascular diseases
- Medical subject headings
- Brain Infarction, Brain Ischemia, Stroke, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AncrodDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InfarctionStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- M G Hennerici, MD, Principal investigator, Univ Heidelberg Klinikum MannheimJean M Orgogozo, MD, Study director, Univ Bordeaux France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343174
- Sponsor's protocol ID
- MPR-CC-0101
- Status last verified
- Jan 2002
- First submitted
- 20 Jun 2006
- Last updated
- 22 Jun 2006
- Results posted
- No
Publications
Hennerici MG, Kay R, Bogousslavsky J, Lenzi GL, Verstraete M, Orgogozo JM; ESTAT investigators. Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial. Lancet. 2006 Nov 25;368(9550):1871-8. doi: 10.1016/S0140-6736(06)69776-6.
PubMed 17126719
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT
- ClinicalTrials.gov ID
- NCT00343174
- Acronym / sponsor ID
- MPR-CC-0101
- Conditions
- Brain Infarction, Cerebral Ischemia, Acute Stroke
- Keywords
- stroke, vascular diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- First posted
- 22 Jun 2006 (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.
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( < 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and above, both sexes
- Acute ischemic stroke with first symptoms within 6 hours of beginning
- Treatment after onset of symptoms
- SSS < 40 at baseline ( consciousness necessary )
Key exclusion criteria (8 listed)
- Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation
- CT evidence of major signs of developing infarction
- Coma
- Prior strokes within 6 weeks
- Severe hypertension (> 220 systolic > 120 mm Hg diastolic)
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 |
|---|---|---|
| Ancrod | Drug | – |
Primary outcome
Not reported in the source record.
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 22 Jun 2006.
- Derived from this study: PubMed 17126719Hennerici MG, Kay R, Bogousslavsky J, Lenzi GL, Verstraete M, Orgogozo JM; ESTAT investigators. Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial. Lancet. 2006 Nov 25;368(9550):1871-8. doi: 10.1016/S0140-6736(06)69776-6.
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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.
M G Hennerici, MD principal investigator
Univ Heidelberg Klinikum Mannheim
Jean M Orgogozo, MD study director
Univ Bordeaux France
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ancrod in people with Brain Infarction and Cerebral Ischemia, run by Heidelberg University.
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 4 inclusion and 8 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 22 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343174, which also lists 1 linked publication.
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 22 Jun 2006.