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

This study has been completed.
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00538967
First received: October 2, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
 Drug: doxycycline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Collagenase mRNA and protein expression [ Time Frame: 2 weeks ]

Enrollment: 60
Study Start Date: May 2002
Study Completion Date: August 2005
Arms Assigned Interventions
No Intervention: 1
Active Comparator: 2
doxycycline 50 mg/day
 Drug: doxycycline
2 weeks once daily
Active Comparator: 3
doxycycline 100 mg
 Drug: doxycycline
2 weeks once daily
Active Comparator: 4
doxycycline 300 mg
 Drug: doxycycline
2 weeks once daily

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective open aneurysm repair

Exclusion Criteria:

  • Severe kidney and liver dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538967

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300RC
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: Jan HN Lindeman, MD, PhD Leiden University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00538967     History of Changes
Other Study ID Numbers: P00.146
Study First Received: October 2, 2007
Last Updated: October 2, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
Collagenases
MMP
Cathepsins
Doxycycline
Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Doxycycline
Doxycycline hyclate
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013