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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03079115
Other study ID # 121-2016006
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 21, 2017
Est. completion date April 30, 2020

Study information

Verified date April 2020
Source Beijing Hospital
Contact Jun Lu, M.D.
Phone +86 10 85136282
Email frente.lu@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to test whether a short-term, high-dose atorvastatin treatment (80mg once a daily (QD) from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS) is superior to conventional-dose atorvastatin treatment (20 mg QD from 3 days before to 30 days after CAS), in terms of efficacy for prevention of periprocedural ischemic brain damage in Chinese patients undergoing CAS.


Description:

Chinese patients with carotid stenosis scheduled for selective CAS will be randomized into two groups. The High-dose Atorvastatin group will receive Atorvastatin 80 mg QD from 3 days before to 3 days after CAS, then 20 mg QD until 30 days after CAS, while the Conventional-dose Atorvastatin group will receive Atorvastatin 20 mg QD from 3 days before to 30 days after CAS. All patients will receive cerebral diffusion-weighted (DW)-MRI within 7 days before CAS. Then, they will also receive repeated DW-MRI within 5 days after CAS. Efficacy for prevention of periprocedural ischemic brain damage of the two different Atorvastatin treatments will be compared, in terms of periprocedural incidence of transient ischemic attack (TIA)/ ischaemic stroke or new ischemic lesions on cerebral DW-MRI.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- = 50% stenosis of internal carotid artery in symptomatic patients; or = 70% stenosis of internal carotid artery in asymptomatic patients

- received statin therapy for = 2weeks before inclusion

Exclusion Criteria:

- nonatherosclerotic carotid disease (dissection, radiation-induced stenosis)

- received endovascular procedure within 30 days before inclusion

- CAS during the procedure of urgent endovascular therapy for acute ischaemic stroke

- need for oral anticoagulant therapy

- high risk of bleeding or contraindications to antiplatelet therapy (eg: platelet count <70 X 109/L)

- active hepatic disease or hepatic dysfunction, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 upper normal limit

- myopathy or increased creatine kinase (CK) > 2 upper normal limit

- renal failure with serum creatinine (Scr) > 3 mg/dl or 264µmol/L

- unable to undergo MRI because of claustrophobia or pacemaker

- pregnancy, lactation, or child bearing potential women without any effective contraception

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
High-dose Atorvastatin
high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)
Conventional-dose Atorvastatin
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).

Locations

Country Name City State
China Beijing Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary brain damage composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS 30 days
Secondary ischemic brain damage-1 incidence of new ischemic lesion on post-CAS DW-MRI within 5 days
Secondary ischemic brain damage-2 number of new lesions on post-CAS DW-MRI within 5 days
Secondary ischemic brain damage-3 incidence of new lesion > 5 mm on post-CAS DW-MRI within 5 days
Secondary ischemic brain damage-4 composite incidence of TIA or ischaemic stroke within 30 days after CAS 30 days
Secondary death, any stroke, or myocardial infarction composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS 30 days
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