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Completed

NCT Number: NCT01707615

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

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

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Key information

Conditions

Atherosclerosis of Arteries of the Extremities, Unspecified Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

43 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSPE

Drug

GSPE 240 mg/day (120mg bid)

Other names: Grape seed proanthocyanidin extrat

lifestyle intervention

Other

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

Primary outcomes

  1. 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.

    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 outcomes

  1. clinical vascular events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jie Qiu

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Acronym: GSPE

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 16, 2012
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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