Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage

NCT00827892 | Completed Phase 2 DMC

• 3 other identifiers: HSC-MS-08-0410P50 NS044227-5P50NS044227
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Treatment; MRI

Outcome Measures

Primary Outcomes (1)

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

  At hospital discharge or Day 14, whichever occurs first.

Secondary Outcomes (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.

  3 months, 6 months, and during hospitalization

Study Arms (2)

1

EXPERIMENTAL

Drug: Pioglitazone

2

PLACEBO COMPARATOR

Drug: Placebo Control

Interventions

Pioglitazone DRUG

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

Also known as: Actos

1

Placebo Control DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.
• GCS \< 6
• Baseline mRS ≥ 3
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 17457822 BACKGROUND

• 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.

  PMID: 19064796 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nicole R Gonzales, MD

  University of Texas Medical School-Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Neurology

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 23, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

US (1)