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

Phase 2

Completed

• Conditions: Atherosclerosis of Arteries of the Extremities, Unspecified
• Interventions: Other: lifestyle intervention; Drug: GSPE

• Registration Number: NCT01707615
• Lead Sponsor: Jie Qiu

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Study First Submitted: 2012-08-14
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-14
• Last Update Submitted: 2012-10-14
• Study First Posted: 2012-10-16
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	lifestyle intervention	In the control group, all patients were enrolled in a lifestyle intervention
GSPE group	GSPE	GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
GSPE group	lifestyle intervention	GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.

Primary Outcome Measures

Name	Time	Method
Carotid B-Mode Ultrasound	Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.	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.

Secondary Outcome Measures

Name	Time	Method
clinical vascular events	after 24 months follow-up	including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.