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Ischemic Cerebrovascular DiseaseORETCRNCT01925872

Optimal Regimen in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance

An observational study of Ischemic Cerebrovascular Disease, run by Zhongrong Miao.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease. 2. Genetic polymorphisms are the most important factors to clopidogrel resistance. 3. The purpose of this study is to find the genes which are the related to clopidogrel resistance. 4. Read more about this study

Who is it for?
Ages 25 to 95 years
Conditions the study is for
Ischemic Cerebrovascular Disease
How many people
2,000 participants
Where
No sites listed yet
Study dates
May 2013to May 2015
Phase
Observational
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 25 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database; 90 days had a stroke or TIA is defined as symptomatic Intracranial atherosclerotic atherosclerosis; Stenosis ≥ 50% (MRI or CT angiography); Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research.

Who may be able to join

  • symptomatic ischemic cerebrovascular disease caused by Intracranial atherosclerotic atherosclerosis research database.
  • 90 days had a stroke or transient ischemic attack is defined as symptomatic Intracranial atherosclerotic atherosclerosis
  • stenosis ≥ 50% (MRI or CT angiography).
  • Intracranial vascular stenosis measured according to the method reported Warfarin aspirin symptomatic intracranial disease research.

Who cannot join

  • diffuse intracranial arterial stenosis.
  • cranial magnetic resonance imaging shows lesions as the branch artery blockage caused.
  • non-atherosclerotic lesions.
  • occurred within 6 weeks of vascular lesions in the region of intracranial hemorrhage.
  • potential cardiac thrombus source.
  • has concurrent intracranial tumors, intracranial aneurysm or arteriovenous malformation.
Show all 15Show fewer
  • ipsilateral extracranial carotid or vertebral artery stenosis ≥ 50%;
  • known to heparin, aspirin, clopidogrel, anesthetics and contrast agents contraindications;
  • hemoglobin less than 10g/dL, platelet count <100000/dL;
  • responsibility left after cerebral vascular-related serious neurological dysfunction (mRS ≥ 3);
  • international normalized ratio> 1.5
  • there are factors that can not be corrected by bleeding;
  • life expectancy <1 year;
  • pregnant or lactating women;
  • indications Commission determines that the patient is not suitable for the study treatment.

About this study

Official title: The Optimal Regimen of Medical Treatment in Endovascular Therapy in Ischemic Cerebrovascular Disease Based on Clopidogrel Resistance

  1. Clopidogrel resistance is common in patients of ischemic cerebrovascular disease.
  2. Genetic polymorphisms are the most important factors to clopidogrel resistance.
  3. The purpose of this study is to find the genes which are the related to clopidogrel resistance.
  4. Through gene sequencing, we can filter patient of clopidogrel resistance, so another drug maybe used to avoid the undesired efficacy.
Keywords
ischemic cerebrovascular disease, Percutaneous transluminal angioplasty and stenting, Clopidogrel resistance

What is being measured

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

  1. genotype, platelet aggregation rate, cerebrovascular events

    Genotype means the genetic polymorphism of ABCB1, CES, CYP2C19, PON1, P2RY12, which can be determined through gene sequencing.

    Measured: 2 years

Secondary outcomes (1)

  1. Active metabolite concentration

    Active metabolite concentration depend on the genetic polymorphism.

    Measured: 2 years

Timeline

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

  1. First posted20 Aug 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2015 (estimated)
  4. Study completionMay 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01925872
Sponsor's protocol ID
BTH-GENE-CR
Acronym
ORETCR
Status last verified
Aug 2013
First submitted
15 Aug 2013
Last updated
28 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • Li XG, Ma N, Sun SS, Xu Z, Li W, Wang YJ, Yang X, Miao ZR, Zhao ZG. Association of genetic variant and platelet function in patients undergoing neuroendovascular stenting. Postgrad Med J. 2017 Sep;93(1103):555-559. doi: 10.1136/postgradmedj-2016-134745. Epub 2017 Mar 9.

    PubMed 28280103

  • Wang B, Li XQ, Ma N, Mo D, Gao F, Sun X, Xu X, Liu L, Song L, Li XG, Zhao Z, Zhao X, Miao ZR. Association of thrombelastographic parameters with post-stenting ischemic events. J Neurointerv Surg. 2017 Feb;9(2):192-195. doi: 10.1136/neurintsurg-2015-011687. Epub 2015 Jun 3.

    PubMed 26041100

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Cerebrovascular Disease, run by Zhongrong Miao.

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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Jan 2015. 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.

Are results available for this study?

Results are not available in the source record.

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?

genotype, platelet aggregation rate, cerebrovascular events (time frame: 2 years). 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 NCT01925872, which also lists 2 linked publications.

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 28 Jan 2015.

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