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

NCT ID: NCT00538967

Last Updated: 2007-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Aortic Aneurysm, Abdominal

Keywords

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Collagenases MMP Cathepsins Doxycycline Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

doxycycline 50 mg/day

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

2 weeks once daily

3

doxycycline 100 mg

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

2 weeks once daily

4

doxycycline 300 mg

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

2 weeks once daily

Interventions

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doxycycline

2 weeks once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective open aneurysm repair

Exclusion Criteria

* Severe kidney and liver dysfunction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Jan HN Lindeman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P00.146

Identifier Type: -

Identifier Source: org_study_id