Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis - Full Text View

Purpose

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

Condition	Intervention
Blood Pressure Variability Intracranial Artery Stenosis	Drug: Amlodipine Drug: ACEI / ARB Drug: Aspirin or Clopidogrel Drug: Atorvastatin

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines

Drug Information available for: Aspirin Amlodipine Amlodipine besylate Clopidogrel bisulfate Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by RenJi Hospital:

Primary Outcome Measures:

the incidence of stroke in a follow-up period [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

blood pressure during the compliance status in a follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
patients with blood pressure variability in a follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Changes in intracranial arterial stenosis and stiffness before and after the follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Other vascular events ( acute ischemic heart disease or vascular death ) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: amlodipine The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )	Drug: Amlodipine The amlodipine - based antihypertensive treatment group (you can add a diuretic or other ) Drug: Aspirin or Clopidogrel aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents) Drug: Atorvastatin Atorvastatin 10 - 40mg / d ( statin therapy)
Experimental: ACEI / ARB ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)	Drug: ACEI / ARB ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other) Drug: Aspirin or Clopidogrel aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents) Drug: Atorvastatin Atorvastatin 10 - 40mg / d ( statin therapy)

Detailed Description:

Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665235

Contacts

Contact: Guowen Shi, MD

86-13651932966

shigw228@126.com

Locations

China, Shanghai
RenJi Hospital	Recruiting
Shanghai, Shanghai, China, 200127
Principal Investigator: Guowen Shi, MD

Sponsors and Collaborators

RenJi Hospital

Investigators

Principal Investigator:

Guowen Shi, MD

RenJi Hospital

More Information

No publications provided

Responsible Party:	Shi Guowen, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier:	NCT01665235 History of Changes
Other Study ID Numbers:	RenJiH-20120804
Study First Received:	August 13, 2012
Last Updated:	August 14, 2012
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Platelet Aggregation Inhibitors
Constriction, Pathologic
Pathological Conditions, Anatomical
Aspirin
Clopidogrel
Amlodipine
Atorvastatin
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Protease Inhibitors
Calcium Channel Blockers

ClinicalTrials.gov processed this record on May 21, 2013