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Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection (RAID)

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ClinicalTrials.gov Identifier: NCT03001739
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jian-cang Zhou M.D., Sir Run Run Shaw Hospital

Brief Summary:
Aortic dissection (AD) aneurysm is a common catastrophic aortic disease in clinical setting. Conservative therapy of heart rate and blood pressure control in the acute phase is the essential treatment as guidelines recommended. Nevertheless, there is no unanimous optimal target for blood pressure in patients with AD so far. The American Heart Association and the Canadian Cardiovascular Society recommend the blood pressure should be controlled to lower than 140/90mmHg, while for patients with diabetes or chronic renal failure, the blood pressure target should be no less than 130/80 mmHg. Recently, the Japanese Circulation Society recommended that the blood pressure should be controlled to no less than 130mmHg. However, there was few large-scale, randomized, controlled studies reported on the effect of different blood pressure control levels on the prognosis of patients with AD. Hence, the intensive control of blood pressure to <120 mmHg, compared to <140 mmHg, may improve the patients' outcome. Thus, in this study, the effect of intensive blood pressure control (<120mmHg) with conventional blood pressure control (<140mmHg) on the prognosis of ABAD patients will be compared, and to identify the therapeutic efficacy of intensive blood pressure control on the ABAD patients.

Condition or disease Intervention/treatment Phase
Blood High Pressure Aortic Dissection Type B Drug: Urapidil Hydrochloride Injection Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Blood PRessure Control in Patients With Acute Type B AortIc Dissection (RAID): Study Protocol for Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Intensive BP control (<120mmHg)
Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to < 120 mm Hg
Drug: Urapidil Hydrochloride Injection
Urapidil Hydrochloride Injection or other antihypertensive agents to decrease the BP to the target level.
Other Name: Urapidil

Active Comparator: Conventional BP control (120-140mmHg)
Urapidil Hydrochloride Injection (100-400ug/min) or other antihypertensive agents to decrease the BP to 120-140 mm Hg
Drug: Urapidil Hydrochloride Injection
Urapidil Hydrochloride Injection or other antihypertensive agents to decrease the BP to the target level.
Other Name: Urapidil




Primary Outcome Measures :
  1. composite in-hospital adverse outcome [ Time Frame: From date of randomization until the date of death from any cause,or permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge, whichever came first, assessed up to 3 months ]
    including death, permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge


Secondary Outcome Measures :
  1. mortality [ Time Frame: 6-month and 1-year after onset of the dissection ]
    All cause mortality

  2. ICU length of stay [ Time Frame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 3 months ]
  3. re-operation or another endovascular intervention for the same problem [ Time Frame: From date of first intervention until the date of second intervention, assessed up to 12 months ]
    any intervention for the same situation such as operation or endovascular intervention



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed patients with Stanford type B acute aortic dissection and systolic blood pressure>160mmHg

Exclusion Criteria:

  • Age <18 years,
  • In pregnancy,
  • Diagnosis of aortic dissection was made 48 hours or more prior,
  • Dissection due to aortic intramural hematoma or penetrating atherosclerotic ulcer,
  • With history of previous surgical or interventional endovascular treatment for aortic diseases,
  • With traumatic aortic injury,
  • With history of cerebrovascular accident, brain surgery, chronic renal insufficiency, and mesenteric vascular thrombosis or dissection,
  • AD patient concomitant with new cerebral infarction, or ischemic mesenteric artery or lower limb arteries which requiring urgent surgical interventions,
  • With obvious contraindications for antihypertensive therapy, such as severe carotid stenosis, cerebral infarction in acute phase ,
  • Pathogenesis of the dissection was due to congenital aortic hypoplasia, such as Marfan syndrome, connective tissue diseases.

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): NCT03001739


Contacts
Contact: Ying-zhi Fang, MD +86 571 86006987

Locations
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Ying-zhi Fang    +86 571 86006987      
Principal Investigator: Yun-song Yu, M.D.         
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
Study Director: Yun-song Yu, MD Zhejiang University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jian-cang Zhou M.D., Principal Investigator, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT03001739     History of Changes
Other Study ID Numbers: 20160920-9
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Antihypertensive Agents
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urapidil
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents