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Antihypertensive
Aggressive Blood Pressure Management for Brain Hemorrhage (ICH-ADAPT II Trial)
Phase 2
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute primary ICH demonstrated with CT scan, within 6 h of symptom onset
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post randomization
Awards & highlights
ICH-ADAPT II Trial Summary
This trial is studying whether aggressive treatment of high blood pressure after brain hemorrhage is better than standard treatment.
Who is the study for?
Adults over 18 with a recent (within 6 hours) brain bleed confirmed by CT scan and high blood pressure can join this trial. It's not for those with severe artery blockage, urgent need to lower BP due to other conditions, secondary causes of the bleed like tumors or trauma, recent strokes, planned surgery for the bleed except drain placement, contrast allergy or certain medication use.Check my eligibility
What is being tested?
This phase II study tests whether lowering blood pressure aggressively after a brain hemorrhage improves outcomes compared to conservative treatment. Patients are randomly assigned to aim for either <140 mmHg or <180 mmHg systolic BP using drugs like labetalol/hydralazine/enalapril within six hours of symptoms starting.See study design
What are the potential side effects?
Possible side effects from medications used in this trial include dizziness, headache, fatigue, low heart rate (for labetalol), fluid retention (for hydralazine), and cough or kidney issues (for enalapril). Monitoring will help detect any adverse reactions early.
ICH-ADAPT II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a brain bleed confirmed by a CT scan within 6 hours of symptoms starting.
Select...
I am 18 years old or older.
ICH-ADAPT II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diffusion-weighted imaging (DWI) lesion frequency
Secondary outcome measures
Absolute hematoma growth
Cumulative diffusion-weighted imaging (DWI) lesion frequency
Functional disability as assessed by the Modified Rankin Scale
ICH-ADAPT II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Target systolic BP <140mmHgExperimental Treatment1 Intervention
Systolic blood pressure will be reduced to <140 mmHg within 1 hour of randomization.
Group II: Target systolic BP <180mmHgActive Control1 Intervention
Systolic blood pressure will be reduced, to <180 mmHg within 1 hour of randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
labetalol/hydralazine/enalapril
2007
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,864 Total Patients Enrolled
25 Trials studying Stroke
2,739 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious illness that is expected to significantly shorten your life.You should not have a pacemaker or any metal objects in your body that could be dangerous during an MRI scan.I cannot have treatments to lower my blood pressure due to severe artery narrowing or serious heart valve disease.I had a stroke caused by a clot less than 90 days ago.I might have a secondary reason for my brain bleed.I am scheduled for surgery to remove a blood clot in my brain.I cannot have CT scans with contrast due to allergies, taking metformin, or high creatinine levels.I had a brain bleed confirmed by a CT scan within 6 hours of symptoms starting.I do not have a disability that required help from others before my current illness.My brain bleed is due to a specific underlying condition like an aneurysm or tumor.I am 18 years old or older.I need immediate treatment to lower my blood pressure due to a severe condition.Your blood pressure is consistently high, with two measurements showing a systolic blood pressure of 140 mmHg or more taken at least 2 minutes apart.My condition started less than 24 hours ago.
Research Study Groups:
This trial has the following groups:- Group 1: Target systolic BP <140mmHg
- Group 2: Target systolic BP <180mmHg
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.
Could you please list the side effects of taking labetalol/hydralazine/enalapril?
"While Phase 2 trials don't usually have data supporting efficacy, this team believes that labetalol/hydralazine/enalapril is safe enough to merit a score of 2."
Answered by AI
What conditions are these drugs commonly used to mitigate?
"By using labetalol/hydralazine/enalapril, medical professionals can help patients that suffer from hypertensive disease, chronic stable angina pectoris, and symptomatic congestive heart failure."
Answered by AI
Does this study still need participants?
"That is correct, the clinicaltrials.gov website says that this research is currently looking for volunteers. The trial was first posted on 8/1/2011 and was last edited on 4/6/2022. They are hoping to have 270 people participate at 2 locations."
Answered by AI
What other drugs have been studied in conjunction with labetalol/hydralazine/enalapril?
"Currently, 24 different studies are underway worldwide studying the effects of labetalol/hydralazine/enalapril. Of these, 7 are large Phase 3 trials. Most of the clinical research for this medication is based in Dayton, Ohio; however, there are 508 total locations where trials are taking place."
Answered by AI
How many people are subjects in this experiment?
"That is correct. The online information available on clinicaltrials.gov shows that the study is still open and recruiting patients. This trial was first posted on August 1st, 2011 and was last updated on April 6th, 2022. They are currently looking for 270 individuals to participate at 2 sites."
Answered by AI
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