Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage (SHRINC)
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.
Drug: Placebo Control
|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|
- 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 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 ]
|Study Start Date:||March 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827892
|United States, Texas|
|Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicole R Gonzales, MD||University of Texas Medical School-Houston|