AN INVESTIGATION INTO THE ROLE OF MATRIX METALLOPROTEINASES (MMP’s) IN LOWER LIMB VASCULAR RESTENOSIS - Role of MMPs in Lower Limb Restenosis
Phase 1
- Conditions
- Post angioplasty and post vein graft stenosis.
- Registration Number
- EUCTR2004-004876-36-GB
- Lead Sponsor
- Addenbrookes Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Patients under the care of the Cambridge Vascular Unit undergoing lower limb angioplasty or infra inguinal bypass grafting.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Unable to give informed consent, Age less than 18years, Pregnancy or planned pregnancy, life expectancy less than 12months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To Study therole of Matrix Mettalloproteinases (MMP) in the process of re-stenosis following angioplasty and vein bypass graft stenosis.;Secondary Objective: Usage of subantimicrobial doses of Doxycycline (20mg twice daily) to inhibit MMPs and thereby limit re-stenosis.;Primary end point(s): MMP activities in SDD versus Placebo. CRP levels. Endothelial function and re-stenosis. Arterial wall stffness and re stenosis.
- Secondary Outcome Measures
Name Time Method