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...
Date First Received: October 2, 2007
Last Updated: October 2, 2007
Verified by: Leiden University Medical Center, October 2007
Clinical Trial Phase: Phase 2 | Start Date: May 2002
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Official Title: “The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: doxycycline
- 2 weeks once daily
Arms, Groups and Cohorts in this Clinical Trial
- No Intervention: 1
- Active Comparator: 2
- doxycycline 50 mg/day
- Active Comparator: 3
- doxycycline 100 mg
- Active Comparator: 4
- doxycycline 300 mg
Outcome Measures for this Clinical Trial
Primary Measures
- Collagenase mRNA and protein expression
- Time Frame: 2 weeks
- Time Frame: 2 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Elective open aneurysm repair
Exclusion Criteria:
- Severe kidney and liver dysfunction
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Leiden University Medical Center
Overall Clinical Trial Officials and Contacts
Jan HN Lindeman, MD, PhD Principal Investigator Leiden University Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00538967
Study ID Number: P00.146
ClinicalTrials.gov Identifier: NCT00538967
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
