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Intensive Blood Pressure Intervention in Stroke (IBIS) Trial (IBIS)

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ClinicalTrials.gov Identifier: NCT03585595
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Tulane University

Brief Summary:
The investigators propose to conduct a multicenter randomized controlled trial to test the effect of a systolic blood pressure target of less than 120 mmHg (intensive treatment) compared to a target of less than 140 mmHg (standard treatment) on the risk of total recurrent stroke (ischemic and hemorrhagic) among patients with a recent ischemic stroke. The study findings will help in the development of clinical guidelines for blood pressure management among patients with ischemic stroke and will have an important global impact on reducing stroke-related morbidity and mortality.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Other: Blood pressure lowering strategy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with a recent ischemic stroke will be randomized to an intensive treatment strategy (a systolic BP target of <120 mmHg) or a standard treatment strategy (a systolic BP target of <140 mmHg) for up to four years.
Masking: Single (Outcomes Assessor)
Masking Description: The participants and study physicians/nurses will not be masked to patient randomization assignments due to different BP targets between the two randomization groups. However, study personnel who collect clinical outcome data at the baseline and follow-up examinations will be masked to patient assignments. The members of the Outcome Adjudication Committee will also be masked to patient randomization.
Primary Purpose: Prevention
Official Title: Intensive Blood Pressure Intervention in Stroke (IBIS) Trial
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Intensive treatment group
Systolic BP target <120 mmHg for the intensive treatment group
Other: Blood pressure lowering strategy
The proposed trial will test a treatment strategy of different systolic BP goals and not specific medications. It remains unclear whether a particular class of antihypertensive drug offers an advantage over others in secondary stroke prevention. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications. However, we will emphasize the use of drugs best demonstrated to be effective in lowering CVD in outcome trials and recommended in current clinical guidelines.

Active Comparator: Standard treatment group
Systolic BP <140 mmHg for the standard treatment group
Other: Blood pressure lowering strategy
The proposed trial will test a treatment strategy of different systolic BP goals and not specific medications. It remains unclear whether a particular class of antihypertensive drug offers an advantage over others in secondary stroke prevention. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications. However, we will emphasize the use of drugs best demonstrated to be effective in lowering CVD in outcome trials and recommended in current clinical guidelines.




Primary Outcome Measures :
  1. Stroke event [ Time Frame: Up to four years of follow-up ]
    Stroke will be diagnosed based on clinical data, including symptoms and signs, computed tomography (CT), and/or magnetic resonance imaging (MRI) of the brain and large vessels.


Secondary Outcome Measures :
  1. Composite major CVD events [ Time Frame: Up to four years of follow-up ]
    Composite outcomes of myocardial infarction, other acute coronary syndrome, stroke, hospitalized or treated heart failure, and CVD deaths.

  2. Myocardial infarction (MI) [ Time Frame: Up to four years of follow-up ]
    MI will be diagnosed based on clinical data, including clinical signs and symptoms, results of cardiac biomarkers of myocardial necrosis, and ECG readings.

  3. Non-MI acute coronary syndrome [ Time Frame: Up to four years of follow-up ]
    Hospitalization for evaluation and treatment of an accelerating or new symptom pattern consistent with coronary artery insufficiency without meeting the definition of MI.

  4. Heart failure [ Time Frame: Up to four years of follow-up ]
    Hospitalization, or an emergency department visit requiring treatment with infusion therapy, for a clinical syndrome that presents with multiple signs and symptoms consistent with cardiac decompensation/ inadequate cardiac pump function.

  5. Dementia [ Time Frame: Up to four years of follow-up ]
    Cognitive function test based on American Psychiatric Association criteria.

  6. All-cause mortality [ Time Frame: Up to four years of follow-up ]
    Deaths form all causes



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged ≥40 years
  • A history of symptomatic, MRI/CT-confirmed ischemic stroke (3-12 months since last acute onset)
  • Systolic BP ≥140 mmHg on 0 medication; 135-180 mmHg on 1 medication; 135-170 mmHg on up to 2 medications; 135-160 mmHg on up to 3 medications; or 135-150 mmHg on up to 4 medications

Exclusion Criteria:

  • Documented symptomatic intracranial and/or extracranial stenosis (≥50%), or asymptomatic intracranial and/or extracranial stenosis (≥70%)
  • Disabling stroke (modified Rankin score of ≥4)
  • Previous intracranial hemorrhage from a non-traumatic cause
  • Any symptoms of orthostatic hypotension during the standing BP measurement, or standing systolic BP <110 mmHg
  • Severe heart failure (NY Heart Association class III and IV) within the past six months or left ventricular ejection fraction (by any method) <35%
  • Any history of atrial fibrillation, ventricular aneurysm, or suspicion of cardioembolic pathology for stroke
  • Other specific cause of stroke identified by routine clinical care (e.g., arteritis, dissection, migraine/vasospasm, drug abuse)
  • Dialysis, eGFR <20 ml/min/1.73 m2, urine protein-to-creatinine ratio ≥1 g/g, or albumin-to-creatinine ratio ≥ 600 mg/g
  • Planned or probable revascularization (any angioplasty or vascular surgery) within three months after screening
  • A medical condition likely to limit survival to less than three years
  • A cancer diagnosed and treated within the past two years that, in the judgment of clinical study staff, would compromise a participant's ability to comply with the protocol and complete the trial (except non-melanoma skin cancer, early-stage prostate cancer, or localized breast cancer)
  • Any factors judged by the clinic team to be likely to limit adherence to the intervention
  • Failure to obtain informed consent from a participant
  • Currently participating in another intervention study
  • Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control

Information from the National Library of Medicine

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): NCT03585595


Contacts
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Contact: Jiang He, MD, PhD 504-988-5165 jhe@tulane.edu
Contact: Yilong Wang, MD, PhD 011-86-13911666571 yilong528@aliyun.com

Sponsors and Collaborators
Tulane University
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Jiang He, MD, PhD Tulane University
Principal Investigator: Yilong Wang Tiantan Hospital, Beijing Capital Medical University

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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT03585595     History of Changes
Other Study ID Numbers: 1109724
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tulane University:
Antihypertensive treatment

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents