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Intracerebral HemorrhagePhase 2SHRINCNCT00827892

Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

A Phase 2 study testing Pioglitazone in people with Intracerebral Hemorrhage, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being independent at 6 months. There is currently no approved treatment for ICH which has been shown to improve outcomes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
Mar 2009to Nov 2013
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

  • age 18-80 years
  • clinical presentation of spontaneous ICH
  • CT scan compatible with spontaneous ICH
  • Time to PIO treatment ≤ 24 hours from symptom onset
  • GCS ≥ 6 on initial presentation OR improvement to a GCS ≥ 6 within the time frame for enrollment
  • Hematoma volume ≥ 5cc on initial head CT.

Who cannot join

  • Participation in another investigational trial in the previous 30 days
  • Patient will undergo surgical evacuation of ICH (ventriculostomy does NOT exclude patient)
  • Inability to undergo neuroimaging with MRI (e.g. pacer, recent stent, inability to lie flat)
  • If patient has mild claustrophobia or agitation amenable to mild sedation (1-2mg lorazepam IV or 5-10mg diazepam PO), he or she may be considered for enrollment. If, however, the patient has severe claustrophobia or agitation, he or she should not be considered for enrollment.
  • GCS < 6
  • Baseline mRS ≥ 3
Show all 19Show fewer
  • Primary intraventricular hemorrhage
  • ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma
  • History of intolerance or allergy to any TZD
  • Thrombocytopenia: platelet count < 100,000
  • Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs ≥ 2x normal, coagulopathy as described above)
  • Co-morbid conditions, which in the opinion of the investigator, are likely to complicate therapy including but not limited to:
  • A history of NYHA class II, III, or IV CHF
  • clinically significant arrhythmia
  • end stage AIDS
  • Pregnancy as determined by a urine pregnancy test
  • Severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30%
  • Malignancy (history of or active)
  • Patient unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Hermann Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being independent at 6 months. There is currently no approved treatment for ICH which has been shown to improve outcomes. In an effort to develop a new treatment for ICH, this research focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing absorption of the blood clot with medication.

Read the detailed description

Intracerebral hemorrhage (ICH) remains a devastating disease and current treatment options lag far behind those for ischemic stroke. Current treatment efforts for ICH are targeted towards the primary brain injury caused by the hemorrhage and growth of the hematoma. This research targets the secondary injury caused by the persistence of toxic blood degradation products in the brain parenchyma.

Based on preclinical work in our lab, the peroxisome proliferator activated receptor-gamma (PPARγ), a member of the nuclear receptor superfamily, represents a possible target for the treatment of ICH aimed at promoting hematoma absorption, limiting the pro-inflammatory response, and protecting salvageable tissue from the damage produced by the persistence of toxic blood degradation products.

Our primary specific aim is to assess the safety of the PPARγ agonist, pioglitazone (PIO) in increasing doses for 3 days, when administered to patients with ICH within 24 hrs of symptom onset. Secondarily, we aim to determine the duration of treatment of PIO for hematoma/edema resolution in ICH. Lastly, we aim to determine whether speed of hematoma/edema resolution in ICH represents a radiographic biological marker of activity which can be correlated with clinical outcome and treatment effect of PIO. The ultimate purpose is to provide baseline data on an aspect of ICH which has not been previously targeted for treatment in an effort to develop a safe and effective treatment strategy that may be practical and applicable for both specialized stroke centers and community hospitals.

Being tested
Pioglitazone, Placebo Control
Keywords
Intracerebral Hemorrhage, Treatment, MRI
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PioglitazoneDrug

    Also called Actos

    Escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI

  • Placebo ControlDrug

    Lactose Capsule administered by mouth daily for the duration of the study as determined by MRI

Study groups in NCT00827892
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Pioglitazone
2Placebo comparatorNot described
Receives: Drug: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary measure of safety will be mortality at discharge.

    Measured: At hospital discharge or Day 14, whichever occurs first.

Secondary outcomes (1)

  1. Secondary measures of safety will include mortality at 3 months and 6 months, symptomatic cerebral edema during hospitalization, clinically significant congestive heart failure, edema, hypoglycemia, anemia, and hepatotoxicity.

    Measured: 3 months, 6 months, and during hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionApr 2013
  4. Study completionNov 2013

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00827892
Sponsor's protocol ID
HSC-MS-08-0410
Other IDs
P50 NS044227-5, P50NS044227
Acronym
SHRINC
Status last verified
Oct 2015
First submitted
21 Jan 2009
Last updated
2 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhao X, Sun G, Zhang J, Strong R, Song W, Gonzales N, Grotta JC, Aronowski J. Hematoma resolution as a target for intracerebral hemorrhage treatment: role for peroxisome proliferator-activated receptor gamma in microglia/macrophages. Ann Neurol. 2007 Apr;61(4):352-62. doi: 10.1002/ana.21097.

    PubMed 17457822

  • Zhao X, Grotta J, Gonzales N, Aronowski J. Hematoma resolution as a therapeutic target: the role of microglia/macrophages. Stroke. 2009 Mar;40(3 Suppl):S92-4. doi: 10.1161/STROKEAHA.108.533158. Epub 2008 Dec 8.

    PubMed 19064796

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone in people with Intracerebral Hemorrhage, run by The University of Texas Health Science Center, Houston 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 6 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: finished, as of the sponsor's last update on 2 Oct 2015. 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. Some participants in this study may receive a placebo. 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?

The primary measure of safety will be mortality at discharge. (time frame: At hospital discharge or Day 14, whichever occurs first.). 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 NCT00827892, which also lists 2 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 2 Oct 2015.

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