Blood Pressure Control for Stroke

(ENCHANTED3/MT Trial)

Recruiting at 1 trial location

Overseen By Xiaoying Chen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The George Institute

Disqualifiers: Contraindications to BP lowering

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 90 days

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the best way to manage blood pressure in people who have had a stroke and received endovascular therapy (EVT). The goal is to determine if different levels of blood pressure control can improve recovery after a stroke. Participants will be randomly assigned to one of three groups: Conservative SBP Control (also known as Conservative Blood Pressure Management or Minimal SBP Reduction), Moderate SBP Control (using the drug Lisinopril, also known as Prinivil or Zestril), or Intensive SBP Control (also referred to as Intensive Blood Pressure Lowering or Intensive Systolic Blood Pressure Control). The trial seeks participants who have undergone EVT within the last 24 hours and have a sustained high blood pressure reading of 150 mmHg or higher.

As an unphased trial, this study provides a unique opportunity to contribute to understanding optimal blood pressure management after EVT.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that managing blood pressure after a stroke can have varying effects. Maintaining blood pressure at a moderate level might be the safest option, as studies suggest it can reduce the risk of another stroke without causing harm. However, excessively lowering blood pressure can lead to serious side effects. While intensive control does not appear to increase stroke risk, it can be dangerous in the first 24 hours after a stroke. Thus, moderate control might offer the best balance, though each approach carries its own risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores different approaches to managing systolic blood pressure (SBP) in stroke patients, which could lead to better recovery and outcomes. Unlike current treatments that often follow a one-size-fits-all strategy, this trial investigates conservative, moderate, and intensive SBP control to tailor treatment based on patient needs. By comparing these methods, researchers hope to uncover the most effective way to control blood pressure and reduce the risk of complications after a stroke. This personalized approach could revolutionize how we treat blood pressure in stroke patients, offering a more customized and potentially more effective care strategy.

What evidence suggests that this trial's treatments could be effective for blood pressure control in stroke patients?

This trial will compare different strategies for blood pressure control after a stroke. Research has shown that lowering systolic blood pressure by 10 points can reduce the chance of having a stroke by up to 41%. Participants in this trial may be assigned to one of the following arms: Conservative SBP Control, Moderate SBP Control, or Intensive SBP Control. Moderately controlling blood pressure, by lowering it 10-20 points, is linked to better recovery after a stroke. More aggressive lowering can help reduce the risk of a stroke caused by bleeding in the brain, but the best target number remains unclear. Overall, studies suggest that both moderate and more aggressive blood pressure control can be helpful, but more research is needed to determine the best approach for care after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Craig Anderson, PhD

Principal Investigator

The George Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke treated with endovascular therapy (EVT) within the last day and have high blood pressure (BP ≥150 mmHg). They must not have other conditions that would exclude them from the study.

Inclusion Criteria

I received a special blood vessel procedure within 24 hours of my symptoms starting.

My blood pressure was 150 or higher after a procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three blood pressure management strategies: conservative, moderate, or intensive, to manage elevated SBP post-EVT in AIS patients.

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 90 days.

90 days

Adaptive Analysis

Adaptive analyses are conducted every 3 months with prespecified statistical triggers for superiority, inferiority, and equivalence.

What Are the Treatments Tested in This Trial?

Interventions

• Conservative SBP Control
• Intensive SBP Control
• Moderate SBP Control

Trial Overview The trial is testing three ways to manage high blood pressure after EVT for stroke: conservative control, moderate control, and intensive control. Patients will be randomly assigned in equal numbers to one of these strategies to find the best BP management approach.

How Is the Trial Designed?

Group I: Moderate SBP Control Experimental Treatment 1 Intervention

Group II: Intensive SBP Control Experimental Treatment 1 Intervention

Group III: Conservative SBP Control Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The George Institute

Lead Sponsor

Trials

84

Recruited

275,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Changhai Hospital

Collaborator

Trials

417

Recruited

553,000+

Published Research Related to This Trial

In a post hoc analysis of the SPRINT trial involving 9361 participants, intensive blood pressure treatment (targeting SBP <120 mmHg) in patients with a baseline SBP of at least 160 mmHg and lower cardiovascular risk was linked to a higher rate of all-cause death compared to standard treatment (targeting SBP <140 mmHg).

Specifically, the intensive treatment group had an annual death rate of 1.86% versus 1.62% in the standard group, with a hazard ratio of 3.12, indicating a significant increase in mortality risk for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased mortality with intensive control in patients with higher baseline SBP and lower Framingham risk. Pan, HY., Lin, HJ., Chen, WJ., et al.[2022]

Maintaining proper cerebral perfusion pressure is crucial in treating acute neurological diseases, as it helps preserve brain function during conditions like hypertensive encephalopathy and stroke.

In cases of ischemic stroke, blood pressure should be gradually reduced over several days to avoid complications, and the ideal antihypertensive medication should precisely control blood pressure without causing severe hypotension or negatively affecting intracranial pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of hypertension in acute neurological diseases]. Kadojić, D.[2009]

In a study of 477,516 treated hypertensive individuals, those with a minimum systolic blood pressure (SBP) below 110 mmHg had a significantly higher risk of serious falls and syncope, with an odds ratio of 2.18, indicating more than double the risk compared to those with SBP of 110 mmHg or higher.

The findings suggest that while intensive blood pressure control is important, maintaining SBP above 110 mmHg may be crucial to prevent adverse outcomes like serious falls and syncope in hypertensive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Systolic Blood Pressure From Treatment and Association With Serious Falls/Syncope. Sim, JJ., Zhou, H., Bhandari, S., et al.[2019]

In a post hoc analysis of the BP TARGET trial involving 318 patients, intensive systolic blood pressure (SBP) treatment after endovascular therapy showed no overall benefit, but diabetic patients may experience a trend towards improved outcomes from this treatment.

Factors such as age, occlusion location, and history of hypertension did not influence the effectiveness of intensive SBP treatment, highlighting that diabetes may play a significant role in modifying treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intensive systolic blood pressure lowering after successful endovascular therapy: a post hoc analysis of the BP TARGET trial. Anadani, M., Maier, B., Escalard, S., et al.[2023]

In a study of 6427 older patients (average age 80) with hypertension, the best cardiovascular outcomes were observed in those with an average systolic blood pressure (SBP) of 120-129 mmHg, indicating a J-shaped relationship between SBP and adverse events.

Maintaining an SBP of less than 130 mmHg was linked to improved health outcomes without significant safety issues, supporting the recommendation to target this level in older patients if they can tolerate it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes according to on-treatment systolic blood pressure in older hypertensive patients: a multicenter cohort using a common data model. Kim, JH., Joo, HJ., Chung, SH., et al.[2023]

Lowering systolic blood pressure (SBP) to 160 mmHg or less using intravenous nicardipine in patients with acute intracerebral hemorrhage (ICH) was found to be safe and well tolerated, with only 0.9% experiencing serious adverse effects.

In a study of 211 patients, neurological deterioration occurred in only 8.1% of cases, and the rates of hematoma expansion and death were within expected ranges, suggesting that this treatment approach is effective in managing blood pressure without significant risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systolic blood pressure lowering to 160 mmHg or less using nicardipine in acute intracerebral hemorrhage: a prospective, multicenter, observational study (the Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-Intracerebral Hemorrhage study). Koga, M., Toyoda, K., Yamagami, H., et al.[2022]

In the STEP trial involving 8283 elderly patients with hypertension, high baseline levels of LDL-C and non-HDL-C were linked to a higher risk of cardiovascular events, indicating that lipid levels can influence cardiovascular risk.

However, the benefits of intensive systolic blood pressure control (targeting 110 to <130 mmHg) were consistent regardless of baseline LDL-C and non-HDL-C levels, suggesting that intensive blood pressure management is effective for all patients, irrespective of their lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of baseline serum cholesterol with benefits of intensive blood pressure control. Wang, X., Feng, Y., Yang, L., et al.[2023]

In a study of 3,628 hypertensive patients in China, only 5% achieved intensive systolic blood pressure (SBP) control (≤130 mmHg), but those with higher education, healthier diets, and combination treatments were more likely to meet this goal.

While there was a trend indicating that more intensive SBP control could reduce the risk of major adverse cardiovascular events and cerebrovascular diseases, the study found no significant overall risk reduction for these outcomes compared to standard SBP control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on the associations of meeting intensive systolic blood pressure control goals with risk for incident cardiovascular and cerebrovascular diseases among the adult hypertensive patients in China]. Yang, HM., Zhao, YX., Lyu, J., et al.[2023]

Lowering systolic blood pressure (SBP) to 120-129 mm Hg is associated with a reduced risk of stroke and major cardiovascular events compared to higher SBP levels, based on a network meta-analysis of 14 trials involving 44,015 patients.

Further reduction of SBP to below 120 mm Hg can significantly decrease stroke risk, but maintaining SBP above 150 mm Hg increases the risk of myocardial infarction and cardiovascular mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the Optimal Systolic Blood Pressure for Hypertensive Patients: A Network Meta-analysis. Fei, Y., Tsoi, MF., Cheung, BMY.[2019]

In the SPRINT study involving 9068 participants, intensive blood pressure treatment initially reduced the risk of serious cardiovascular events, but this benefit diminished after about 3.4 years of follow-up.

Factors such as cumulative systolic blood pressure and serious adverse events during treatment may negatively impact the long-term efficacy of intensive hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cumulative SBP and serious adverse events on efficacy of intensive blood pressure treatment: a randomized clinical trial. Rueda-Ochoa, OL., Rojas, LZ., Ahmad, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666043/

Blood Pressure Management in Stroke: Viewpoint - PMC In a meta-analysis of 45 RCTs, 10 mm Hg lowering of SBP resulted in 41% reduction in stroke incidence [15]. ... SBP targets on CVD outcomes, all-cause mortality ...

2. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.14653

Blood Pressure Management in Stroke | Hypertension A more recent meta-analysis, based on 54 RCTs, reported a 27% reduction in stroke incidence for every 10-mm Hg decrement in SBP (RR, 0.73 [95% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5466289/

Blood Pressure Management for Stroke Prevention and in ... With more intensive SBP lowering of <130 mm Hg, the stroke risk was further reduced (0.53, 0.38–0.75), but the risk of serious adverse events also increased ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06352619

Study Details | NCT06352619 | Third Enhanced Control of ... Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic ...

5. ahajournals.org ahajournals.org/doi/10.1161/SVIN.123.001234

Intensive Versus Conservative Blood Pressure Target After ... We performed a meta‐analysis of RCTs comparing intensive versus conservative BP target for patients following EVT after acute ischemic stroke.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815387

Intensive vs Conventional Blood Pressure Control After ... These findings suggest that intensive BP reduction post thrombectomy does not offer benefits and may pose risks.

7. tandfonline.com tandfonline.com/doi/full/10.1080/08037051.2025.2475314

intensive versus conservative blood pressure lowering ... We found no benefit of the intensive lowering of BP on mortality rates and incidence of ICH compared to the conservative BP management.