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

August 14, 2012
October 14, 2012
October 2006
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01707615 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Atherosclerosis of Arteries of the Extremities, Unspecified
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
287
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
43 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01707615
2010GGC10294
Yes
Jie Qiu, Shandong University
Jie Qiu
National Natural Science Foundation of China
Study Director: Jie Qiu, doctor Qilu Hospital
Shandong University
October 2012

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