Statins for Digital Ulcers and Raynaud's Phenomenon in systemic sclerosis
| ISRCTN | ISRCTN26319635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26319635 |
| Protocol serial number | N/A |
| Sponsor | University of Alexandria (Egypt) |
| Funder | Investigator intiated and funded (Egypt) |
- 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
Scientific
12 Heliopolis Street
Camp Cesar
Alexandria
-
Egypt
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure(s) |
The primary outcome measure is the number of new digital ulcers occurring during the study period, measured monthly. |
| Key secondary outcome measure(s) |
1. The Scleroderma Health Assessment Questionnaire subsets for dressing/grooming (SHAQ-DI) |
| Completion date | 05/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
-
Egypt
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
