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Pioglitazone Supplement with Surgery for Intracerebral Hemorrhage (ENRICHPLUS Trial)
Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Consent by patient or LAR to MIS evacuation of the ICH based on best medical practice
CT scan demonstrating an acute, spontaneous, primary basal ganglia ICH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 90, 120, and 180 days
Awards & highlights
ENRICHPLUS Trial Summary
This trial will study the effects of combining an early treatment for brain bleed with a drug on 20 people with the condition, and compare results with similar subjects who only receive the treatment. It will take 2 yrs.
Who is the study for?
Adults aged 18-80 with a specific type of stroke (primary basal ganglia intracerebral hemorrhage) who can start treatment within 24 hours. They must have a certain level of consciousness and be able to consent to surgery. Excluded are those with other brain conditions, severe reactions to pioglitazone, heavy drug/alcohol use, liver/kidney disease, or need for immediate anticoagulation.Check my eligibility
What is being tested?
The trial is testing the addition of Pioglitazone (a diabetes medication) to early minimally invasive surgery for stroke patients. It compares outcomes with those who only receive surgery as part of another study over two years.See study design
What are the potential side effects?
Pioglitazone may cause side effects like headache, muscle pain, sinus irritation or infection, sore throat and fluid retention which could worsen heart failure in some cases.
ENRICHPLUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to a minimally invasive surgery to remove a brain hemorrhage.
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My CT scan shows a recent stroke in a deep part of my brain.
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I am between 18 and 80 years old.
Select...
I started pioglitazone within 24 hours after my symptoms began.
Select...
I have no or minimal disability from my condition.
ENRICHPLUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30, 90, 120, and 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 90, 120, and 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Improvement - modified Rankin Scale (mRS)
Secondary outcome measures
Economic
Hematoma
Safety: Number of Participants with 30-day mortality
+4 moreSide effects data
From 2011 Phase 4 trial • 130 Patients • NCT015884702%
Mild weight gain ~2kg with ankle edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pioglitazone
ENRICHPLUS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MIPS + PioglitazoneExperimental Treatment1 Intervention
20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks
Group II: MIPS AloneActive Control1 Intervention
This trial will compare it's subjects to subjects who have previously undergone MIPS for evacuation of ICH using the BrainPath access device as part of the ENRICH trial (NCT02880878). These subjects will be enrolled at an ENRICH trial site independent of our Institution. Deidentified patient information from 20 subjects in this group, who will be matched to those in the ENRICH-PLUS group, will be provided to the principal investigator for comparison of outcomes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone 15mg
2021
Completed Phase 4
~770
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
691 Previous Clinical Trials
376,706 Total Patients Enrolled
Nico CorporationIndustry Sponsor
3 Previous Clinical Trials
5,420 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific amount of bleeding in your brain, calculated using a method called ABC/2.I agree to a minimally invasive surgery to remove a brain hemorrhage.My CT scan shows a recent stroke in a deep part of my brain.I have been told I have less than 6 months to live and am focusing on comfort care.You don't have a stable place to live, or you have had problems with drugs or alcohol that could make it hard for you to follow the study rules.You are allergic or cannot tolerate TZD1.Your Glasgow Coma Score is between 5 and 14.My stroke treatment can start within 24 hours of my first symptoms.I am not pregnant, surgically sterilized, or post-menopausal.I am between 18 and 80 years old.Your blood platelet count is less than 75,000.You have a medical condition that causes your blood to take longer to clot.I need anticoagulation soon but can't take Coumadin in the first 30 days.I have heart failure, diagnosed or shown in recent tests.I am currently experiencing bleeding in areas such as my stomach, lungs, or urinary tract.I use blood thinners that can't be quickly reversed or have a clotting disorder.I do not have severe kidney or liver disease with active bleeding problems.I started pioglitazone within 24 hours after my symptoms began.My blood clotting time (INR) remains above 1.4 despite treatment.You have a mechanical heart valve, but it's okay if you have a bioprosthetic valve.I have type 2 diabetes and am on insulin or oral medication, but can switch to pioglitazone if my doctor agrees.My stroke symptoms are mild and I don't have severe brain swelling or damage.More than half of one of my brain's ventricles is affected by bleeding.My stroke was in the deeper parts of my brain or in the lower back part.I have had bleeding in the brain due to a burst blood vessel or other vascular issues.Your liver function tests show high levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin.I have no or minimal disability from my condition.
Research Study Groups:
This trial has the following groups:- Group 1: MIPS Alone
- Group 2: MIPS + Pioglitazone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this research study limited to individuals over 40 years old?
"In accordance with the study's regulations, only those aged 18 or above and below 80 years old can be considered for enrolment."
Answered by AI
What is the maximum scope of individuals eligible to participate in this experiment?
"Affirmative. Clinicaltrials.gov records indicate that this clinical trial is currently recruiting participants, having been first posted on May 1st 2023 and recently updated on the 8th of the same month. The study requires a total of 20 individuals for enrollment at one location only."
Answered by AI
Who meets the criteria for enrolling in this experiment?
"In order to be accepted, applicants must possess intracerebral hemorrhage and lie within the age range of 18-80 years old. This trial is looking for a cohort of 20 individuals."
Answered by AI
Are there any opportunities to join this research initiative?
"Affirmative. According to clinicaltrials.gov, the trial that was posted on May 1st of 2023 is currently searching for patients. Modifications were made as recently as May 8th, and a total of 20 participants are required at one site."
Answered by AI
What potential dangers should be taken into account when considering the use of MIPS + Pioglitazone?
"Our Power team has deemed the safety of MIPS + Pioglitazone to be a 2 because, while there is evidence attesting to its security, efficacy data is still lacking."
Answered by AI
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