Acute StrokePhase 3NCT00975962
New Acute Treatment for Stroke - The Effect of Remote PERconditioning
A Phase 3 study testing Actilyse and Thrombolysis + remote perconditioning in people with Acute Stroke, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Actilyse and Thrombolysis + remote perconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Mar 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant ischemic stroke suspicion (NIHSS 1-24) and paresis of an extremity.
- Treatment with rtPa within 4.5 hours from debut of symptoms.
- Age above 18 (changed from 01.01.2010 to no upper age limit)
- Independent in daily living before the acute onset of symptoms. (mrs</=2)
- MR scan showing DWI lesion, consistent with acute ischemic stroke.
Who cannot join
- Contraindications for iv rtPA
- Onset of symptoms older than 4.5 hours
- Previous diseases of the brain: Intracranial aneurisms or arteriovenous malformations. Brain surgery or hemorrhagic stroke. Former ischemic stroke within the last 3 months.
- Heart diseases: Infectious endocarditis or suspicion of septic emboli, pericarditis, ventricular thrombosis, aneurisms of the heart wall or major heart failure.
- Serious diseases: Cancer, AIDS, dementia, significant abuse, renal failure, liver diseases such as liver failure, cirrhosis, portal hypertension, active hepatitis.
- Pregnancy
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- Major ischemic stroke where the patient is unconscious.(NIHSS > 25).
- Symptoms suspect for migraine, Multiple sclerosis, TIA or another neurological disease than ischemic stroke.
- MR scan:
- Contraindications for MRI scans
- Tumor cerebri, cerebral abscesses
- Known hypersensitivity to Gadovist or any of its ingredients, acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2), acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
- Caution with using Gadovist to patients with severe cardiovascular disease, and only to be used after a risk-benefit assessment.
- Caution with using Gadovist in patients with low threshold for seizures.
- Lab data:
- Blood glucose < 2, 8 mmol/l or > 22 mmol/l
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Aarhus University Hospital
Aarhus, Aarhus, 8000
About this study
This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.
The aims of this study are:
- To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
- To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.
Read the detailed description
Final inclusion and informed consent takes place after first MRI in patients eligible for rtPA.
Follow-up MRI after 24h and 1 month. Clinical outcome at 3 months.
- Conditions
- Acute Stroke
- Being tested
- Actilyse, Thrombolysis + remote perconditioning
- Keywords
- Stroke, Neuroprotection, remote preconditioning, Salvage index (%): Difference in infarct growth (PWI-DWI)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActilyseDrug
Actilyse according to guidelines without pretreatment with remote persconditioning
Thrombolysis + remote perconditioningProcedure or surgery
The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC.
| Study group | Role | What they receive |
|---|---|---|
| Thrombolysis + Remote perconditioning | Experimental | Remote perconditioning (rIPerC) undertaken in ambulance on rute to hospital in case of suspected stroke.
The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC. Receives: Procedure: Thrombolysis + remote perconditioning |
| Thrombolysis | Active comparator | Thrombolysis without pretreatment with remote perconditioning Receives: Drug: Actilyse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.
Measured: February 2012
Secondary outcomes (1)
Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
Measured: February 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2011
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 Acute StrokeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Aase and Ejnar Danielsens Foundation, Danish National Research Foundation
- Investigators
- Grethe Andersen, M.D Doctor, Principal investigator, Department of Neurology Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975962
- Sponsor's protocol ID
- VEK 19752
- Status last verified
- Jun 2011
- First submitted
- 11 Sep 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
PubMed 24203849
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Acute Treatment for Stroke - The Effect of Remote PERconditioning
- ClinicalTrials.gov ID
- NCT00975962
- Acronym / sponsor ID
- VEK 19752
- Conditions
- Acute Stroke
- Keywords
- Stroke, Neuroprotection, remote preconditioning, Salvage index (%): Difference in infarct growth (PWI-DWI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- TRYG Foundation, Aase and Ejnar Danielsens Foundation, Danish National Research Foundation
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Sep 2009 (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 is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.
The aims of this study are:
- To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
- To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.
Detailed description
Final inclusion and informed consent takes place after first MRI in patients eligible for rtPA.
Follow-up MRI after 24h and 1 month. Clinical outcome at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombolysis + Remote perconditioning | Experimental | Procedure: Thrombolysis + remote perconditioningRemote perconditioning (rIPerC) undertaken in ambulance on rute to hospital in case of suspected stroke. The rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC. |
| Thrombolysis | Active comparator | Drug: ActilyseThrombolysis without pretreatment with remote perconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Significant ischemic stroke suspicion (NIHSS 1-24) and paresis of an extremity.
- Treatment with rtPa within 4.5 hours from debut of symptoms.
- Age above 18 (changed from 01.01.2010 to no upper age limit)
- Independent in daily living before the acute onset of symptoms. (mrs</=2)
- MR scan showing DWI lesion, consistent with acute ischemic stroke.
Key exclusion criteria (16 listed)
- Contraindications for iv rtPA
- Onset of symptoms older than 4.5 hours
- Previous diseases of the brain: Intracranial aneurisms or arteriovenous malformations. Brain surgery or hemorrhagic stroke. Former ischemic stroke within the last 3 months.
- Heart diseases: Infectious endocarditis or suspicion of septic emboli, pericarditis, ventricular thrombosis, aneurisms of the heart wall or major heart failure.
- Serious diseases: Cancer, AIDS, dementia, significant abuse, renal failure, liver diseases such as liver failure, cirrhosis, portal hypertension, active hepatitis.
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 |
|---|---|---|
| ActilyseActilyse according to guidelines without pretreatment with remote persconditioning | Drug | Thrombolysis |
| Thrombolysis + remote perconditioningThe rIPerC consists of 4 cycles of 5 minute total occlusion of blood flow to the non-paretic arm separated by 5 minutes of reperfusion. The occlusion is secured by inflating a standard blood pressure cuff to 25 mmHg above the systolic blood pressure. Written instruction on cuff inflation and paramedic's documentation of their procedure were written in a standard report which was turned over to a study nurse upon arrival to the hospital, and filed. The investigators were hence blinded to the prehospital rIPerC. | Procedure or surgery | Thrombolysis + Remote perconditioning |
Primary outcome
Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated.
Time frame: February 2012
1 secondary outcome
Final size of the infarct (T2 MRI after 1 month). Final infarct size adjusted after prognostic factors.
Time frame: February 2012
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 23 Jun 2011.
- Derived from this study: PubMed 24203849Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
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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.
Grethe Andersen, M.D Doctor principal investigator
Department of Neurology Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Actilyse and Thrombolysis + remote perconditioning in people with Acute Stroke, run by Aarhus University Hospital at 1 site in Denmark.
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 5 inclusion and 16 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 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.
What does the primary outcome measure?
Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (time frame: February 2012). 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 NCT00975962, 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 23 Jun 2011.