Phase 2 N=24 Randomized Triple-blind Treatment

Atorvastatin for Microvascular Endothelial Function and Raynaud in Early Diffuse Scleroderma

Scleroderma

Bottom Line

View on ClinicalTrials.gov: NCT02370784 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Aug 2020

Primary outcome: Primary: Proportion of Patients Improving Their EndoPAT Reactive Hyperemia Index (RHI) at the End-of-study (16 Weeks) — 6; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: atorvastatin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Robyn T. Domsic, MD, MPH
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Improving Their EndoPAT Reactive Hyperemia Index (RHI) at the End-of-study (16 Weeks)	6; 4	—
SECONDARY Change in the Raynaud Condition Score (RCS) at 16 Weeks (End-of-study) From Baseline	-2.0; 0	—
SECONDARY The Median Change in the Raynaud Phenomenon Visual Analog Scale (RP-VAS) Score at 16 Weeks (End-of-study) Compared to Baseline in the Atorvastatin and Placebo Groups.	0.5; 0.0	—
SECONDARY % of Patients Who Improved Their Brachial Flow-mediation Dilation (%FMD) at 16 Weeks	5; 5	—

Summary

The purpose of this study is to learn about the effect atorvastatin on blood vessel function and Raynaud symptoms in patients with early diffuse systemic sclerosis. Systemic sclerosis is a disease characterized by blood vessel injury, immune system activation and fibrosis. Blood vessel injury is thought to be important early in the disease. Blood vessel complications of systemic sclerosis include Raynaud phenomena, finger and toe ulcers, and pulmonary hypertension. While atorvastatin reduces cholesterol, it is recognized to have many effects beyond cholesterol reduction. These include improvement of blood vessel function and reduction of fibrosis. We hypothesize that treatment with atorvastatin over 16 weeks will improve blood vessel function and Raynaud symptom in patients with early diffuse systemic sclerosis. We hope that by targeting therapy early in the disease we may delay blood vessel changes and improve Raynaud symptoms.

Eligibility Criteria

Inclusion Criteria

early diffuse scleroderma (< 3 years from the first scleroderma-related symptom)
Raynaud phenomenon
no use of lipid-lowering medication within 60 days

Exclusion Criteria

pregnancy
renal or kidney dysfunction (creatinine < 2.0 mg/dL or creatinine clearance < 60 c/min)
diabetes mellitus
known cardiovascular disease or a prior history of stroke
history of liver disease
new or changed dose of calcium channel blockers (CCB) and angiotensin receptor blockers (ARBs) in the last 4 weeks
known allergy or adverse reaction to the atorvastatin or another statin drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02370784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.