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

Jie Qiu

Status and phase: Completed; Phase 2

Conditions: Atherosclerosis of Arteries of the Extremities, Unspecified

Treatments: Other: lifestyle intervention; Drug: GSPE

Study type: Interventional

Funder types: Other

Identifiers

NCT01707615

2010GGC10294

Details and patient eligibility

About

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

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 43 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

control group

Other group

Description:

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

Treatment:

Other: lifestyle intervention

GSPE group

Active Comparator group

Description:

GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.

Treatment:

Other: lifestyle intervention

Drug: GSPE