Statins for Digital Ulcers and Raynaud's Phenomenon in systemic sclerosis

ISRCTN	ISRCTN26319635
DOI	https://doi.org/10.1186/ISRCTN26319635
Secondary identifying numbers	N/A

Submission date: 05/12/2007
Registration date: 10/12/2007
Last edited: 01/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anna Abou-Raya
Scientific

12 Heliopolis Street
Camp Cesar
Alexandria
-
Egypt

Study information

Study design	Randomised double-blind placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Statins: a potentially useful therapeutic option in the management of systemic sclerosis-related Raynaud's phenomenon and digital ulcers
Study acronym	SDURP
Study objectives	Systemic Sclerosis (SSc) is a chronic connective tissue disorder characterised by excessive cutaneous and visceral fibrosis, an aberrant immune activation and widespread, pronounced alterations in the microvasculature with structural and functional vasculopathy. Statins have an effect on endothelial dysfunction and thus may help ameliorate Raynaud's phenomenon and digital ulcers characteristic of SSc.
Ethics approval(s)	Ethics approval received from the Ethics Committee of the Faculty of Medicine, University of Alexandria on the 13th of September, 2005.
Health condition(s) or problem(s) studied	Systemic Sclerosis (SSc)
Intervention	The patients are divided into 2 groups: Group 1: assigned to receive 40 mg/day of atorvastatin for four months Group 2: assigned to identical placebo tablets for four months Seventy-five healthy age-sex-matched volunteers serve the purpose of controls.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atorvastatin
Primary outcome measure	The primary outcome measure is the number of new digital ulcers occurring during the study period, measured monthly.
Secondary outcome measures	1. The Scleroderma Health Assessment Questionnaire subsets for dressing/grooming (SHAQ-DI) 2. Eating and hand grip 3. Assessment of safety and tolerability of the atorvastatin therapy All secondary outcomes are measured monthly.
Overall study start date	30/09/2005
Completion date	05/05/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	80
Key inclusion criteria	1. Raynaud's phenomenon 2. A history of a documented digital ulcer secondary to SSc within the last 12 months despite ongoing vasodilator therapy 3. Aged between 25 - 60 years, both male and female
Key exclusion criteria	1. Smoking 2. Diabetes mellitus 3. Hypercholesterolaemia 4. Hypertension 5. Cardiac insufficiency 6. Coexisting hepatic and renal diseases and drugs known to interact with statins
Date of first enrolment	30/09/2005
Date of final enrolment	05/05/2006

Locations

Countries of recruitment

Egypt

Study participating centre

12 Heliopolis Street

Alexandria
-
Egypt

Sponsor information

University of Alexandria (Egypt)
University/education

Faculty of Medicine
12 Heliopolis Street
Camp Cesar
Alexandria
-
Egypt

Phone	+20 (0)3 5924035
Email	annaaraya@yahoo.com
Website	http://www.alexmed.org
"ROR"	https://ror.org/00mzz1w90

Funders

Funder type

Other

Investigator intiated and funded (Egypt)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008		Yes	No