Effects of atorvastatin on microcirculatory endothelial function in patients with systemic sclerosis - Atorvastatin in systemic sclerosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003775-21-GB

Enrollment

Registered

2005-11-10

Start date

2008-08-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis (also termed 'scleroderma')

Interventions

Trade Name: Lipitor Product Name: Lipitor Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A diagnosis of systemic sclerosis 2. Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age 75 years 2. Pregnancy or breast feeding 3. Other contraindications to statin therapy (hypersensitivity, active liver disease, unexplained persistent elevations of serum transaminases).

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that statin therapy (atorvastatin to be investigated in this study) has beneficial effects on microvascular endothelial function in patients with systemic sclerosis.; Secondary Objective: To investigate the effects of atorvastatin on: 1. Endothelial-independent vasodilation 2. Capillary structure, as measured by nailfold videomicroscopy 3. Von Willebrand factor (a marker of endotheial activation/damage) and high sensitivity C-reactive protein ; Primary end point(s): The primary end-point of the study will be endothelial-dependent vasocilation. This will be assessed by response to iontophoresis with acetylcholine chloride (ACh) as measured by laser Doppler imaging as in previous studies from our department.	—

Measure

Time frame

Main Objective: To test the hypothesis that statin therapy (atorvastatin to be investigated in this study) has beneficial effects on microvascular endothelial function in patients with systemic sclerosis.; Secondary Objective: To investigate the effects of atorvastatin on: 1. Endothelial-independent vasodilation 2. Capillary structure, as measured by nailfold videomicroscopy 3. Von Willebrand factor (a marker of endotheial activation/damage) and high sensitivity C-reactive protein ; Primary end point(s): The primary end-point of the study will be endothelial-dependent vasocilation. This will be assessed by response to iontophoresis with acetylcholine chloride (ACh) as measured by laser Doppler imaging as in previous studies from our department.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026