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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00587717
Other study ID # 485-02
Secondary ID Merck #02005
Status Completed
Phase N/A
First received
Last updated
Start date September 2002
Est. completion date March 2006

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing carotid endarterectomy - No previously known side effects of statins - Patients who will sign an informed consent - Age > 18 years old - No signs of current infection Exclusion Criteria: - Patient hypersensitive to any component of this medication - Patients with acute liver disease (AST> normal value) - Patients with chronic liver disease (history of Hepatitis B or C) - Patients with renal failure (creatinine > 3.0) - Patients with unexplained muscle pains and aches - Patients with rheumatoid arthritis - Patients with Lupus - Current cancer treatment - Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone - Pregnant females

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
simvastatin
Two 80 mg pills simvastatin taken 24 hours prior to surgery
placebo
take 2 80 mg pills placebo 24 hours prior to surgery

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Merck Sharp & Dohme LLC

Outcome

Type Measure Description Time frame Safety issue
Primary This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure. 24 prior to surgery
See also
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Active, not recruiting NCT01445613 - Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy N/A
Terminated NCT01414387 - Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting N/A
Completed NCT00406055 - CHOICE: Carotid Stenting For High Surgical-Risk Patients Phase 4
Completed NCT00403078 - SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
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Completed NCT00402740 - Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) N/A
Completed NCT00287508 - Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study) Phase 4
Completed NCT00178672 - A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease Phase 4
Recruiting NCT02850588 - SVS VQI TransCarotid Revascularization Surveillance Project
Completed NCT02759653 - Norwegian Carotid Plaque Study
Withdrawn NCT01042912 - Frequency Analysis of Carotid Artery Disease N/A
Completed NCT00530504 - Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study N/A

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