Clinical trial NCT00970918: Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs
Official title: Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular disease
Carotid Intima Media Thickness
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 2609
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent.
* Patients with at least two CVD risk factors but not on lipid-lowering agents

Exclusion Criteria:

* Subjects with CHD, any conditions that may affect hs-CRP levels.
* Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.

Primary outcomes:
measure: Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs
timeFrame: IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
Secondary outcomes:
measure: Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs
timeFrame: Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Gurgaon
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Meerut
country: India
facility: Research Site
city: Denpasar
country: Indonesia
facility: Research Site
state: Bali
city: Bandung-Jawa
country: Indonesia
facility: Research Site
state: Barat
city: Semarang-Jawa
country: Indonesia
facility: Research Site
state: Tengah
city: Surabaya
country: Indonesia
facility: Research Site
state: Timur
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
state: Sarawak
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
state: Taipei
city: Shilin
country: Taiwan
facility: Research Site
state: Taipei
city: Taoyuan
country: Taiwan
facility: Research Site
state: Taipei
city: Patumwan
country: Thailand
facility: Research Site
state: Bangkok
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
state: Ho Chi Min
city: Hanoi
country: Vietnam
facility: Research Site
Study officials:
affiliation: Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095
name: Guy Yeoman, MD
role: STUDY_DIRECTOR
References: