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

This study has been completed.

Sponsor:

Collaborator:

National Natural Science Foundation of China

Information provided by (Responsible Party):

Jie Qiu, Shandong University

ClinicalTrials.gov Identifier:

NCT01707615

First received: August 14, 2012

Last updated: October 14, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 14, 2012

Last Updated Date

October 14, 2012

Start Date ^ICMJE

October 2006

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Carotid B-Mode Ultrasound [ Time Frame: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months. ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01707615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

clinical vascular events [ Time Frame: after 24 months follow-up ] [ Designated as safety issue: Yes ]

including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Atherosclerosis of Arteries of the Extremities, Unspecified

Intervention ^ICMJE

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

Other Name: Grape seed proanthocyanidin extrat
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

Study Arm (s)

control group
In the control group, all patients were enrolled in a lifestyle intervention

Intervention: Other: lifestyle intervention
Active Comparator: GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
Interventions:
- Drug: GSPE
- Other: lifestyle intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

287

Completion Date

October 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

43 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01707615

Other Study ID Numbers ^ICMJE

2010GGC10294

Has Data Monitoring Committee

Yes

Responsible Party

Jie Qiu, Shandong University

Study Sponsor ^ICMJE

Jie Qiu

Collaborators ^ICMJE

National Natural Science Foundation of China

Investigators ^ICMJE

Study Director:

Jie Qiu, doctor

Qilu Hospital

Information Provided By

Shandong University

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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