Condition category
Circulatory System
Date applied
01/04/2008
Date assigned
29/10/2008
Last edited
29/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ling Feng

ORCID ID

Contact details

Department of Neurosurgery
Xuanwu Hospital of Capital Medical University
Changchun Road
Xuanwu District
Beijing
100053
China
ling-feng@vip.163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of Symptomatic Middle cerebral artery (MCA) stenosis: Endovascular versus Drug therapy

Acronym

RaSMED

Study hypothesis

Intracranial arteriostenosis is one of the main causes of stroke. Although anti-platelet and anti-coagulation therapy are widely applied nowadays, the effectiveness of such methods is still controversial. Each treatment method has its advantages and disadvantages. There is evidence that anti-coagulation and anti-platelet therapies are not effective to all patients.

Endovascular therapy has been applied for several years, including stent technology and dilation with balloon, which has only been proven to be effective by a single-centre trial with a small size. Designing a randomised controlled trial is necessary to supply evidence to prove the effectiveness of endovascular therapy, which can also supply evidence for standardising the therapy of intracranial stenosis. Our study hypothesises that endovascular method is not inferior to medication.

Ethics approval

Xuanwu Hospital Ethics Board gave approval on the 19th March 2008 (ref: XW-EA-08008)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intracranial atherosclerotic stenosis

Intervention

Drug therapy:
Clopidogrel 75 mg and aspirin 100 mg every day (QD), maintaining such a plan for 3 months. After that, aspirin 100 mg or clopidogrel 75 mg should be retained.

Endovascular therapy:
In this group, all the patients should take dual-antiplatelet drugs 3 - 5 days before treatment (clopidogrel 75 mg and aspirin 100 mg, every day). General anaesthesia will be selected, all the patients will receive stent-planting therapy. After the endovascular therapy, the anti-platelet drugs will be continued for 3 months. And then, one of the anti-platelet drugs will be maintained for the rest of life. Anticoagulation therapy will be applied for only 3 days after the stent-planting.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The patient died or experienced stroke within 30 days after the beginning of treatment
2. The stent does not cover the lesion or stenosis can't be retrieved completely (less than 50%)

Secondary outcome measures

DSA should be performed after six months if the patient receives endovascular therapy or the patient experiences stroke which is related to the target vessel.

Overall trial start date

01/01/2008

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 25 - 75 years old (both genders) - half/bilateral stenosis on the M1 segment of the MCA - which is related to the onset of the cerebral ischaemia
2. Digital subtraction angiography (DSA) should be performed to verify such points as follows:
2.1. The degree of vascular stenosis should be greater than or equal to 70%
2.2. The length of lesion should be within 10 mm
2.3. The diameter of distal vessel should be more than 2 mm
3. Asymptomatic vascular stenosis greater than or equal to 50%
4. Atherosclerotic stenosis
5. National Institutes of Health Stroke Score (NIHSS) less than 15, and modified Rankin Scale (mRS) less than or equal to 3
6. The patient should be tolerant to both of the anti-platelet drugs
7. The patient should not be pregnant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

166

Participant exclusion criteria

1. Acute cerebral stroke occurs in the past one week, which is correlated to the vascular lesion
2. Those patients who have diseases of a haemorrhagic tendency
3. Anticipation of life span is within one year, especially in those patients who have a combined malignant disease
4. Acute dissecting aneurysm; vascular lesion is due to vasculitis, moya-moya disease, vasculopathy because of radiation, muscle fibrodysplasia
5. Calcification can be observed in the lesion segment, which is difficult to be dilated. Thrombus can be seen in the lumen of blood vessel.
6. Intracranial haematoma, tumour, brain arteriovenous malformation (BAVM), intracranial aneurysm (AM) (not including an AM whose diameter is less than 5 mm, and that is located in a different circle region)
7. Patients are excluded:
7.1. When there is a contraindication to heparin
7.2. When they are not tolerant to x-rays or anaesthesia
7.3. When their haemoglobin is less than 10 g/dL or their platelet is less than 100000/l
8. Patients who received thrombolysis in the past 24 hours
9. Symptomatic coronary artery disease, where revascularisation is needed
10. Surgical intervention has been performed in the last one month or will be performed in the next three months
11. Endovascular therapy was performed in the same target vessel previously
12. Multi-stenosis are found in the same target vessel, the degree of which is more than 50%
13. Stent-planting is hard to be performed because of the circuitry of the vessels
14. Symptomatic intracranial arterial stenosis is found not only in one vessel

Recruitment start date

01/01/2008

Recruitment end date

01/03/2009

Locations

Countries of recruitment

China

Trial participating centre

Department of Neurosurgery
Beijing
100053
China

Sponsor information

Organisation

Beijing Municipal Science and Technology Commission (China)

Sponsor details

Xizhimen South Road 16#
Beijing
100053
China
+86 (0)10 6615 3395
bjkwwz@sina.com

Sponsor type

Government

Website

http://www.bjkw.gov.cn/n1143/index.html

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (China) - Beijing Scientific Project (ref: D0905004040131)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes