Atherosclerosis of Arteries of the Extremities, UnspecifiedPhase 2GSPENCT01707615
Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Atherosclerotic Plaques in Clinical Use
A Phase 2 study testing GSPE and lifestyle intervention in people with Atherosclerosis of Arteries of the Extremities, Unspecified, run by Jie Qiu.
Trial summary
The purpose of this study is to investigate the antiatherogenic effect of GSPE in clinical use Read more about this study
- Who is it for?
- Ages 43 to 75 years
- Conditions the study is for
- Atherosclerosis of Arteries of the Extremities, Unspecified
- What is being tested?
- GSPE and lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Being tested
- GSPE, lifestyle intervention
- Keywords
- proanthocyanidin,atherosclerosis, carotid plaque
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSPEDrug
Also called Grape seed proanthocyanidin extrat
GSPE 240 mg/day (120mg bid)
lifestyle interventionOther
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 group | Role | What they receive |
|---|---|---|
| control group | Other | In the control group, all patients were enrolled in a lifestyle intervention Receives: Other: lifestyle intervention |
| GSPE group | Active comparator | GSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention. Receives: Drug: GSPE; Other: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid B-Mode Ultrasound
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.
Measured: Carotid ultrasound examination was performed at baseline and 6, 12, 24months after treatment.The change of carotid plaque was record within 24 months.
Secondary outcomes (1)
clinical vascular events
including hospital readmission for unstable angina, myocardial infarction, stroke, TIA, an arterial revascularization procedure (percutaneous coronary revascularization or coronary bypass surgery) and cardiac death.
Measured: after 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2006
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of Arteries of the Extremities, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Jie Qiu, Shandong University
- Investigators
- Jie Qiu, doctor, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707615
- Sponsor's protocol ID
- 2010GGC10294
- Acronym
- GSPE
- Status last verified
- Oct 2012
- First submitted
- 14 Aug 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Grape Seed Proanthocyanidin Extrat on Progression of Carotid Intima-media Thickness and Atherosclerotic Plaques in Clinical Use
- ClinicalTrials.gov ID
- NCT01707615
- Acronym / sponsor ID
- GSPE / 2010GGC10294
- Keywords
- proanthocyanidin,atherosclerosis, carotid plaque
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Jie QiuUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Oct 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: lifestyle interventionIn the control group, all patients were enrolled in a lifestyle intervention |
| GSPE group | Active comparator | Drug: GSPE, Other: lifestyle interventionGSPE 240 mg/day (120mg bid) in addition to the same lifestyle intervention. |
Who may qualify
- Ages
- 43 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSPEAlso: Grape seed proanthocyanidin extratGSPE 240 mg/day (120mg bid) | Drug | GSPE group |
| lifestyle interventiondietary 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 | Other | GSPE group, control group |
Primary outcome
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.
1 secondary outcome
clinical vascular events
Time frame: after 24 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Qiu, doctor study director
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSPE and lifestyle intervention in people with Atherosclerosis of Arteries of the Extremities, Unspecified, run by Jie Qiu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.