Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use

Atherosclerosis of Arteries of the Extremities, Unspecified Clinical Trial

— GSPE  

Official title:

Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707615
• Other study ID #: 2010GGC10294
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: October 14, 2012
• Start date: October 2006
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use

Description:

Atherosclerotic plaques indicate the occurrence of ischemia events and how to deal with it is a difficult task for clinical physicians. Grape seed proanthocyanidin extrat (GSPE) has been reported to exert an antiatherogenic effect by inducing regression of atherosclerotic plaques in animal experimental studies. In this study, the antiatherogenic effect of GSPE has been investigated in clinical use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 43 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) carotid ultrasound examination: presence of carotid plaque or abnormal CIMT of between 0.9 and 1.2mm; (2) lipid profile: LDL?3.12mmol/L, TC?5.2mmol/L; (3) no lipid-lowering treatment within the past 6 months.

Exclusion Criteria:

• severe cardiomyopathy, acute coronary syndrome, hepatic dysfunction, end-stage renal failure (serum creatinine =117mmol/L), prior carotid endarterectomy, and/or patients who did not agree to participate in the present study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Atherosclerosis of Arteries of the Extremities, Unspecified
• Plaque, Atherosclerotic

Intervention

Drug:
• GSPE
GSPE 240 mg/day (120mg bid)

Other:
• lifestyle intervention
dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jie Qiu	National Natural Science Foundation of China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid B-Mode Ultrasound	The common, internal, and external carotid arteries were carefully identified by combining B-mode ultrasonography and color-Doppler duplex examination in the anterior oblique, lateral, and posterior oblique planes. All data was collected in 12 segments: the near (intimal-luminal surface) and far (medial- adventitial) walls of the distal common (1 cm proximal to dilation of the carotid bulb), the bifurcation (1cm proximal to the flow divider), and the proximal internal (1 cm section of the internal carotid artery immediately distal to the flow divider) left and right carotid artery.	Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.	No
Secondary	clinical vascular events	including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.	after 24 months follow-up	Yes