The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm - Tabular View

Tracking Information

First Received Date ^ICMJE

October 2, 2007

Last Updated Date

October 2, 2007

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Collagenase mRNA and protein expression [ Time Frame: 2 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

Official Title ^ICMJE

The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

Brief Summary

The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.

Detailed Description

In this clinical trial, we evaluated the effect of two weeks of low (50 mg/day), medium (100 mg/day) or high dose (300 mg/day) doxycycline versus no medication in patients undergoing elective AAA repair. The effect of doxycycline treatment on MMP and cysteine proteases, and their respective inhibitors was evaluated in an integrative approach.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Aortic Aneurysm, Abdominal

Intervention ^ICMJE

Drug: doxycycline

Study Arms / Comparison Groups

Active Comparator: doxycycline 50 mg/day
Active Comparator: doxycycline 100 mg
Active Comparator: doxycycline 300 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elective open aneurysm repair

Exclusion Criteria:

Severe kidney and liver dysfunction

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00538967

Responsible Party

Study ID Numbers ^ICMJE

P00.146

Study Sponsor ^ICMJE

Leiden University Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jan HN Lindeman, MD, PhD

Leiden University Medical Center

Information Provided By

Leiden University Medical Center

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP