Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

NCT01665235 | Unknown DMC

• 1 other identifier: RenJiH-20120804
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis

Conditions

Blood Pressure Variability; Intracranial Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• the incidence of stroke in a follow-up period

  one year

Secondary Outcomes (4)

• blood pressure during the compliance status in a follow-up

  one year

• patients with blood pressure variability in a follow-up

  one year

• Changes in intracranial arterial stenosis and stiffness before and after the follow-up

  one year

• Other vascular events ( acute ischemic heart disease or vascular death )

  one year

Study Arms (2)

amlodipine

ACTIVE COMPARATOR

The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )

Drug: Amlodipine; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin

ACEI / ARB

EXPERIMENTAL

ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

Drug: ACEI / ARB; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin

Interventions

Amlodipine DRUG

The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )

amlodipine

ACEI / ARB DRUG

ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

ACEI / ARB

Aspirin or Clopidogrel DRUG

aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)

ACEI / ARB; amlodipine

Atorvastatin DRUG

Atorvastatin 10 - 40mg / d ( statin therapy)

ACEI / ARB; amlodipine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age : ≥ 18 years of age , ≤ 75 years old
• with intracranial artery stenosis in ischemic stroke
• the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference
• the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis
• MRS score ≤ 3 points

You may not qualify if:

• vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke
• associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners
• severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%
• With extracranial artery stenosis, especially carotid and vertebral artery stenosis .
• patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy
• Incomplete clinical data collection in patients

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Interventions

Amlodipine; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Clopidogrel; Atorvastatin

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Guowen Shi, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guowen Shi, MD

CONTACT

86-13651932966; shigw228@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

CN (1)