Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage (SHRINC)
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|ClinicalTrials.gov Identifier: NCT00827892|
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : October 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Pioglitazone Drug: Placebo Control||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||November 2013|
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
- The primary measure of safety will be mortality at discharge. [ Time Frame: At hospital discharge or Day 14, whichever occurs first. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827892
|United States, Texas|
|Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Nicole R Gonzales, MD||University of Texas Medical School-Houston|