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Trial record 28 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

High Dose Atorvastatin for Preventing Periprocedural Ischemic Brain Damage During Carotid Artery Stenting (PICAS)

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ClinicalTrials.gov Identifier: NCT03079115
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Lu, Beijing Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Drug: High-dose Atorvastatin Drug: Conventional-dose Atorvastatin Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Two Different Doses of Atorvastatin for Prevention of Periprocedural Ischemic Brain Damage in Chinese Patients Undergoing Carotid Artery Stenting (CAS)
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-dose Atorvastatin Arm
High dose Atorvastatin (80 mg QD from 3 days before to 3 days after carotid artery stenting, thereafter conventional dose of Atorvastatin with 20mg QD until 30 days after CAS)
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)
Other Name: Lipitor

Conventional-dose Atorvastatin Arm
Conventional dose Atorvastatin (20mg QD from 3 days before to 30 days after CAS)
Drug: Conventional-dose Atorvastatin
conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
Other Name: Lipitor




Primary Outcome Measures :
  1. brain damage [ Time Frame: 30 days ]
    composite incidence of new ischemic lesion on post-CAS cerebral DW-MRI, TIA or ischaemic stroke within 30 days after CAS


Secondary Outcome Measures :
  1. ischemic brain damage-1 [ Time Frame: within 5 days ]
    incidence of new ischemic lesion on post-CAS DW-MRI

  2. ischemic brain damage-2 [ Time Frame: within 5 days ]
    number of new lesions on post-CAS DW-MRI

  3. ischemic brain damage-3 [ Time Frame: within 5 days ]
    incidence of new lesion > 5 mm on post-CAS DW-MRI

  4. ischemic brain damage-4 [ Time Frame: 30 days ]
    composite incidence of TIA or ischaemic stroke within 30 days after CAS

  5. death, any stroke, or myocardial infarction [ Time Frame: 30 days ]
    composite incidence of death, any stroke, or myocardial infarction within 30 days after CAS



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079115


Contacts
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Contact: Jun Lu, M.D. +86 10 85136282 frente.lu@hotmail.com
Contact: Xin Wang +86 10 58115037 wangxinannie@126.com

Locations
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China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang    +8613661174001    wangxinannie@126.com   
Sponsors and Collaborators
Beijing Hospital

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Responsible Party: Jun Lu, Attending Physician; MD, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03079115     History of Changes
Other Study ID Numbers: 121-2016006
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jun Lu, Beijing Hospital:
Atorvastatin

Additional relevant MeSH terms:
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Carotid Stenosis
Brain Injuries
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors