Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use (GSPE)
This study has been completed.
Sponsor:
Jie Qiu
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
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Purpose
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis of Arteries of the Extremities, Unspecified |
Drug: GSPE Other: lifestyle intervention |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use |
Resource links provided by NLM:
Further study details as provided by Shandong University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 287 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
control group
In the control group, all patients were enrolled in a lifestyle intervention
|
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
|
|
Active Comparator: GSPE group
GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 43 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jie Qiu, Qilu Hospital of Shandong University, Shandong University |
| ClinicalTrials.gov Identifier: | NCT01707615 History of Changes |
| Other Study ID Numbers: | 2010GGC10294 |
| Study First Received: | August 14, 2012 |
| Last Updated: | October 14, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shandong University:
|
proanthocyanidin,atherosclerosis, carotid plaque |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Plaque, Atherosclerotic Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Proanthocyanidin Procyanidin Grape Seed Extract Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013