RestenosisPhase 3BPRIASNCT01405248

Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting

A Phase 3 study testing Butylphthalide in people with Restenosis, run by Jinling Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether butylphthalide are effective for Preventing Restenosis after Intracranial and Extracranial Artery Stenting Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Restenosis
What is being tested?: Butylphthalide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: Jul 2011to Jan 2014
Phase: Phase 3
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 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

. DSA check to be sure, the VA, BA ICA, MCA, PCA and other major blood vessels, have corresponding stenosis of symptoms more than 50%, not corresponding symptoms stenosis of greater than 70%;
. A successful cerebrovascular carotid stenting noted.

Who cannot join

. There is a serious bleeding tendency, nearly three months have intracranial bleeding or cranial out blood;
. Active peptic ulcer;
. Not good control high blood pressure; the wickedness of
. Blood vessel distortion, variation, narrow degree badly, can not be implemented stents operation;
. Serious cardiopulmonary etc medical problems;
. Those allergic to celery;
. Contrast agents allergy;
. Can't complete follow-up.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Neurology ;Jinling Hospital
Nanjing, Jiangsu, 210002

Other trials in China

About this study

The purpose of this study is to determine whether butylphthalide are effective for Preventing Restenosis after Intracranial and Extracranial Artery Stenting

Read the detailed description

Ischemic stroke is a significant cause of death, most of the patients is caused by atherosclerosis,current treatments include internal medicine medications, interventional treatment and so on,among them, the interventional therapy can make narrow blood vessels blood recovery fastly,and for its small trauma,Gradually accepted by psychiatrist, But stents are easy to narrow has been plagued by everybody ,At present, prevent restenosis stent is mainly of antiplatelet therapy,But,prevention effect is not obvious often easy to appear harmful response,how to effectively reduce postoperative restenosis, become the majority concern of patients and doctors .Clinical trials showed that, butylbenzene can promote the function of ischemic stroke recovery patients. Animal pharmacodynamics study suggests that this product can block the ischemic stroke of brain damage caused by DuoGe pathological link, with strong against ischemic and brain protection, especially can obviously increase in small brains ischemia ATP and phosphoric acid creatine level, decrease local cerebral ischemia in rats, reduce infarct size, cerebral edema improved energy metabolism and brain ischemia of microcirculation and blood flow in the brain, restrain the nerve cell apoptosis, and has the cerebral thrombosis and anti-platelet aggregation function. Research shows that, butylbenzene phthalocyanine influence through arachidonic acid (AA) metabolism, selective inhibition and their metabolites from DuoZhong mediated pathophysiological events, can remove microvascular spasms. Inhibit platelet aggregation, restrain TXA2 synthesis, scavenging free radicals, thereby through many ways, many link blocking caused by cerebral ischemia the pathophysiology of development process. These mechanisms may make butylbenzene in preventing phthalocyanine intracranial carotid stenting noted restenosis and related ischemia of events play an important role.

Conditions: Restenosis
Being tested: Butylphthalide, Placebo
Keywords: Butylphthalide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ButylphthalideDrug
Also called NBP
20 mg/time per os three times a day. 180days
PlaceboDrug
20 mg/time per os three times a day. 180days

Study groups in NCT01405248
Study group	Role	What they receive
Butylphthalide	Experimental	Single center of the placebo control a double-blind randomized control study to evaluate Butylphthalide prevention stents restenosis effect Receives: Drug: Butylphthalide
control	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

occlusion and restenosis
Stenosis detected by DSA(digital subtraction angiography), CTA(CT angiography) or MRA(MR angiography) was measured according to NASCET (North American Symptomatic Carotid Endarterectomy Trial) method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET = (1-md/C)×100%.
Measured: one year

Secondary outcomes (1)

NIHSS, mRS
NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stening, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stening and butylphthalide therapy.
Measured: at one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jan 2014

First posted29 Jul 2011 (estimated)
Study startJul 2011
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for RestenosisStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405248
Sponsor's protocol ID: BPRIAS
Acronym: BPRIAS
Status last verified: Oct 2015
First submitted: 28 Jul 2011
Last updated: 26 Oct 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI

All Restenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting
ClinicalTrials.gov ID: NCT01405248
Acronym / sponsor ID: BPRIAS / BPRIAS
Conditions: Restenosis
Keywords: Butylphthalide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Jinling Hospital, ChinaUniversity, hospital or other
Collaborators: CSPC-NBP Pharmaceutical Co., Ltd.
Study start: Jul 2011
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 29 Jul 2011 (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 determine whether butylphthalide are effective for Preventing Restenosis after Intracranial and Extracranial Artery Stenting

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Butylphthalide	Experimental	Drug: ButylphthalideSingle center of the placebo control a double-blind randomized control study to evaluate Butylphthalide prevention stents restenosis effect
control	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

. DSA check to be sure, the VA, BA ICA, MCA, PCA and other major blood vessels, have corresponding stenosis of symptoms more than 50%, not corresponding symptoms stenosis of greater than 70%;
. A successful cerebrovascular carotid stenting noted.

Key exclusion criteria (8 listed)

. There is a serious bleeding tendency, nearly three months have intracranial bleeding or cranial out blood;
. Active peptic ulcer;
. Not good control high blood pressure; the wickedness of
. Blood vessel distortion, variation, narrow degree badly, can not be implemented stents operation;
. Serious cardiopulmonary etc medical problems;

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
ButylphthalideAlso: NBP20 mg/time per os three times a day. 180days	Drug	Butylphthalide
Placebo20 mg/time per os three times a day. 180days	Drug	control

Primary outcome

occlusion and restenosis
Time frame: one year
Stenosis detected by DSA(digital subtraction angiography), CTA(CT angiography) or MRA(MR angiography) was measured according to NASCET (North American Symptomatic Carotid Endarterectomy Trial) method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET = (1-md/C)×100%.

1 secondary outcome

NIHSS, mRS
Time frame: at one year

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 26 Oct 2015.

Related trials for Restenosis

Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI

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.

Xinfeng Liu, MD study chair

Department of Neurology, Jinling Hospital, Nanjing University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Butylphthalide in people with Restenosis, run by Jinling Hospital, China at 1 site in China.

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 2 inclusion and 8 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 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

occlusion and restenosis (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405248.

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 26 Oct 2015.