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Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage (SHRINC)

This study is currently recruiting participants.
Verified June 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Nicole Gonzales, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00827892
First received: January 21, 2009
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Intracerebral Hemorrhage
 Drug: Pioglitazone
Drug: Placebo Control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • The primary measure of safety will be mortality at discharge. [ Time Frame: At hospital discharge or Day 14, whichever occurs first. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 months, 6 months, and during hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pioglitazone
Escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI
Other Name: Actos
Placebo Comparator: 2 Drug: Placebo Control
Lactose Capsule administered by mouth daily for the duration of the study as determined by MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participation in another investigational trial in the previous 30 days
  2. Patient will undergo surgical evacuation of ICH (ventriculostomy does NOT exclude patient)

  3. Inability to undergo neuroimaging with MRI (e.g. pacer, recent stent, inability to lie flat)

    a. 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.

  4. GCS < 6
  5. Baseline mRS ≥ 3
  6. Primary intraventricular hemorrhage
  7. ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma
  8. History of intolerance or allergy to any TZD
  9. Thrombocytopenia: platelet count < 100,000
  10. Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs ≥ 2x normal, coagulopathy as described above)

  11. Co-morbid conditions, which in the opinion of the investigator, are likely to complicate therapy including but not limited to:

    1. A history of NYHA class II, III, or IV CHF
    2. clinically significant arrhythmia
    3. end stage AIDS
  12. Pregnancy as determined by a urine pregnancy test
  13. Severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30%
  14. Malignancy (history of or active)
  15. Patient unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827892

Contacts
Contact: Nicole R Gonzales, MD 713-500-7109 Nicole.R.Gonzales@uth.tmc.edu
Contact: Navdeep S Sangha, MD 713-500-7043 Navdeep.S.Sangha@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Nicole R Gonzales, MD University of Texas Medical School-Houston
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Nicole Gonzales, Assistant Professor - Neurology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00827892     History of Changes
Other Study ID Numbers: HSC-MS-08-0410, P50 NS044227-5
Study First Received: January 21, 2009
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Intracerebral Hemorrhage
Treatment
MRI

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013