StrokeMISPNCT02383121
Midodrine for Ischemic Stroke With Penumbra
An observational study of Stroke, run by University of Utah at 1 site in United States.
Trial summary
Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading cause of long-term disability. Early neurological deterioration after AIS typically occurs within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher rate of death or poor outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Midodrine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 10 May 2017
- Phase
- Observational
- 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
Study population: This study has been withdrawn
Who may be able to join
- Adult patients, ≥ 18 years old, with anterior circulation acute ischemic stroke on diffusion-weighted imaging (DWI) MRI, defined as predominant stroke burden in the frontal, parietal, or temporal lobes.
- Demonstrable neurologic deficit due to stroke at randomization.
- Within 12 hours of randomization, measured on CT or MR perfusion: a cerebral blood flow (CBF)/DWI ratio ≥1.25, an absolute difference between the CBF and DWI lesions of ≥15 mL, and a DWI volume between 20-100 mL. (Quantified with the Olea software)
- Enrollment within 24 hours from stroke onset
Who cannot join
- Endovascular therapy or intravenous tPA treatment for stroke
- Acute myocardial infarction on ECG or troponin T >0.01 ng/mL.
- History of cardiac disease, including myocardial infarction or unstable angina within the last 3 months, any history of clinically significant arrhythmia, symptomatic valvular disease, dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, left-ventricular assist device, or known ejection fraction < 25%.
- Glomerular filtration rate < 50, serum creatinine >1.5 mg/dl, severe urinary retention, or end-stage renal disease on dialysis.
- Coagulopathy, including INR >1.5, PTT >40, platelet count <75, or use of a novel anticoagulant in the last 3 days (e.g. dabigatran, rivaroxaban, apixaban).
- Positive pregnancy test.
Show all 19Show fewer
- Clinical and laboratory evidence of thyrotoxicosis.
- Severe Peripheral Vascular Disease or Raynaud's syndrome.
- Systolic blood pressure (SBP) >180 or diastolic blood pressure (DBP) >100 immediately prior to randomization.
- Allergy or history of adverse reaction to IV phenylephrine or midodrine.
- Hemorrhage within the area of DWI lesion on MRI.
- Indication for anticoagulation within 5 days of stroke onset.
- Arterial dissection or cerebral aneurysm.
- Pre-stroke modified Rankin score of >2.
- Evidence of bacterial endocarditis.
- Indication for carotid endarterectomy or stenting in next 5 days.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Failure of post-stroke swallow evaluation and no alternative enteric access (e.g. nasogastric feeding tube, percutaneous endoscopic gastrostomy tube).
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading cause of long-term disability. Early neurological deterioration after AIS typically occurs within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher rate of death or poor outcome. Several mechanisms account for early neurological deterioration, including hemorrhagic conversion, systemic illness, cerebral edema, and seizure, but the most common cause is extension of the stroke into the "penumbra," a region of salvageable brain tissue surrounding the core of irreversible ischemic infarct. The penumbra is tenuously perfused by collateral blood vessels. AIS management is primarily focused on recanalizing the occluded artery causing the stroke, but an alternative and relatively unexplored approach is optimization of collateral blood flow.
Over 60% of AIS patients present with a transient acute hypertensive response, which is theorized to be the result of either increased sympathoadrenal tone, poorly controlled underlying hypertension, or an unknown stroke-specific mechanism related to augmenting cerebral perfusion through collateral blood flow. Epidemiological data suggests worse stroke outcomes are associated with extremes of sustained hypo- or hypertension, which has led to dozens of clinical trials involving over 20,000 patients to determine if pharmacologically lowering blood pressure after AIS is beneficial. The results have been persistently neutral or negative. In contrast, there have been no major clinical trials on the efficacy of using vasopressor medications to maintain or increase baseline blood pressure after AIS, despite promising preclinical data and pilot studies that showed no increase in cerebral hemorrhage or edema. The only randomized trial of vasopressor use after AIS demonstrated an improvement in clinical outcomes, but there was no difference in mean blood pressure between the control and intervention arms, suggesting the beneficial effect was not exclusively related to induced hypertension. One possibility is that the vasopressor reduced blood pressure variability, which preliminary data has shown to be detrimental after AIS, although that aspect of neurovascular coupling has not been adequately studied in the acute phase after AIS.
The reliance on IV vasopressors, which are only administered in the intensive care unit, is a fundamental limitation of prior research. An alternative, but untested, approach is to use the oral vasopressor midodrine hydrochloride. We hypothesize that frequent midodrine dosing after AIS can optimize collateral blood flow and help salvage the ischemic penumbra. The objective of this study is to develop tools to quantify midodrine's effect on blood pressure and the ischemic penumbra.
- Conditions
- Stroke
- Being tested
- Midodrine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Also called Acute ischemic patients
Not appliciable
| Study group | Role | What they receive |
|---|---|---|
| No patients | Study has been withdrawn Receives: Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the effect of midodrine on blood pressure mean and variability
Measured: During study drug administration
Secondary outcomes (2)
The physiologic impact of midodrine. (daily mean flow velocity (MFV) in cm/second, of both the parent artery to the stroke and other reference intracranial arteries)
The outcome measure is a daily mean flow velocity (MFV) in cm/second, of both the parent artery to the stroke and other reference intracranial arteries.
Measured: Days 1-4
The radiologic impact of midodrine. (percentage change in the size of the stroke (%)
The outcome measure is the size of the initial stroke in cm3 on day 1, and record the size of the final stroke in cm3 on the follow-up MRI at 3-4 days after enrollment. The investigators will then calculate a percentage change in the size of the stroke (%).
Measured: Day 1 and Day 3-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start10 May 2017
- Primary completion10 May 2017
- Study completion10 May 2017
Why it stopped: Changed study to an observational study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam de Havenon, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383121
- Sponsor's protocol ID
- IRB_76683
- Acronym
- MISP
- Status last verified
- May 2017
- First submitted
- 27 Feb 2015
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine for Ischemic Stroke With Penumbra
- ClinicalTrials.gov ID
- NCT02383121
- Acronym / sponsor ID
- MISP / IRB_76683
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Changed study to an observational study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 9 Mar 2015 (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.
Acute ischemic stroke (AIS) affects over 700,000 Americans every year and is the leading cause of long-term disability. Early neurological deterioration after AIS typically occurs within 72 hours of stroke onset and affects 30% of all stroke patients, who have a higher rate of death or poor outcome. Several mechanisms account for early neurological deterioration, including hemorrhagic conversion, systemic illness, cerebral edema, and seizure, but the most common cause is extension of the stroke into the "penumbra," a region of salvageable brain tissue surrounding the core of irreversible ischemic infarct. The penumbra is tenuously perfused by collateral blood vessels. AIS management is primarily focused on recanalizing the occluded artery causing the stroke, but an alternative and relatively unexplored approach is optimization of collateral blood flow.
Over 60% of AIS patients present with a transient acute hypertensive response, which is theorized to be the result of either increased sympathoadrenal tone, poorly controlled underlying hypertension, or an unknown stroke-specific mechanism related to augmenting cerebral perfusion through collateral blood flow. Epidemiological data suggests worse stroke outcomes are associated with extremes of sustained hypo- or hypertension, which has led to dozens of clinical trials involving over 20,000 patients to determine if pharmacologically lowering blood pressure after AIS is beneficial. The results have been persistently neutral or negative. In contrast, there have been no major clinical trials on the efficacy of using vasopressor medications to maintain or increase baseline blood pressure after AIS, despite promising preclinical data and pilot studies that showed no increase in cerebral hemorrhage or edema. The only randomized trial of vasopressor use after AIS demonstrated an improvement in clinical outcomes, but there was no difference in mean blood pressure between the control and intervention arms, suggesting the beneficial effect was not exclusively related to induced hypertension. One possibility is that the vasopressor reduced blood pressure variability, which preliminary data has shown to be detrimental after AIS, although that aspect of neurovascular coupling has not been adequately studied in the acute phase after AIS.
The reliance on IV vasopressors, which are only administered in the intensive care unit, is a fundamental limitation of prior research. An alternative, but untested, approach is to use the oral vasopressor midodrine hydrochloride. We hypothesize that frequent midodrine dosing after AIS can optimize collateral blood flow and help salvage the ischemic penumbra. The objective of this study is to develop tools to quantify midodrine's effect on blood pressure and the ischemic penumbra.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No patients | – | Drug: MidodrineStudy has been withdrawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study has been withdrawn
Key inclusion criteria (4 listed)
- Adult patients, ≥ 18 years old, with anterior circulation acute ischemic stroke on diffusion-weighted imaging (DWI) MRI, defined as predominant stroke burden in the frontal, parietal, or temporal lobes.
- Demonstrable neurologic deficit due to stroke at randomization.
- Within 12 hours of randomization, measured on CT or MR perfusion: a cerebral blood flow (CBF)/DWI ratio ≥1.25, an absolute difference between the CBF and DWI lesions of ≥15 mL, and a DWI volume between 20-100 mL. (Quantified with the Olea software)
- Enrollment within 24 hours from stroke onset
Key exclusion criteria (19 listed)
- Endovascular therapy or intravenous tPA treatment for stroke
- Acute myocardial infarction on ECG or troponin T >0.01 ng/mL.
- History of cardiac disease, including myocardial infarction or unstable angina within the last 3 months, any history of clinically significant arrhythmia, symptomatic valvular disease, dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, left-ventricular assist device, or known ejection fraction < 25%.
- Glomerular filtration rate < 50, serum creatinine >1.5 mg/dl, severe urinary retention, or end-stage renal disease on dialysis.
- Coagulopathy, including INR >1.5, PTT >40, platelet count <75, or use of a novel anticoagulant in the last 3 days (e.g. dabigatran, rivaroxaban, apixaban).
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 |
|---|---|---|
| MidodrineAlso: Acute ischemic patientsNot appliciable | Drug | No patients |
Primary outcome
Investigate the effect of midodrine on blood pressure mean and variability
Time frame: During study drug administration
2 secondary outcomes
The physiologic impact of midodrine. (daily mean flow velocity (MFV) in cm/second, of both the parent artery to the stroke and other reference intracranial arteries)
Time frame: Days 1-4
The radiologic impact of midodrine. (percentage change in the size of the stroke (%)
Time frame: Day 1 and Day 3-4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Utah at 1 site in United States.
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 19 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: withdrawn, as of the sponsor's last update on 17 May 2017. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Investigate the effect of midodrine on blood pressure mean and variability (time frame: During study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2017; AzTrials last refreshed its copy on 4 Nov 2026.