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The effects of doxycycline treatment on inflammation and endothelial function in advanced atherosclerosis


- candidate number3685
- NTR NumberNTR1389
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2008
- Secondary IDsP05.189 METC LUMC
- Public TitleThe effects of doxycycline treatment on inflammation and endothelial function in advanced atherosclerosis
- Scientific TitleThe effects of doxycycline treatment on inflammation and endothelial function in advanced atherosclerosis
- ACRONYMN/A
- hypothesisDoxycycline will ameliorate the vascular condition and inflammatory status in patients with mild to moderate atherosclerotic disease
- Healt Condition(s) or Problem(s) studiedInflammation, Peripheral arterial disease (PAD), Atherosclerosis , Doxycycline
- Inclusion criteria1. Patients suffering from mild to moderate stable peripheral arterial disease who do not require carotis or femoral endarteriectomy (Fontaine IIa)
- Exclusion criteria1. Known hypersensitivity for tetracycline derivates
2. Patients treated with antibiotics in last 3 months for other diseases then lower urinary tract infections
3. Patients treated with immunosuppressive agents (including steroids)
4. Patients treated with fibrates
5. Patients with Diabetes Mellitus regulated with drug therapy
6. Signs of kidney or liver failure
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-aug-2008
- Target number of participants15
- InterventionsPatients were (if necessary) pre-treated with or switched to simvastatin 40 mg daily at least four weeks prior to trial start.
Patients were treated with 100 mg doxycycline for four weeks
- Primary outcomeEndothelial function
- Secondary outcomePlasma markers
- Timepointst=0, follow up after 30, 60, 90 and 120 days
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan H. Lindeman
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan H. Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Vascular Surgery
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsIn progress
- Brief summaryPatients with mild to moderate peripheral arterial disease were treated with doxycycline 100mg daily or placebo.
Reduction in vascular inflammation was assessed by measuring vascular endothelial function and peripheral plasma markers of inflammation.
- Main changes (audit trail)
- RECORD23-jul-2008 - 6-aug-2008


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