Plain English Summary
Background and study aims
Scleroderma is an uncommon autoimmune disease that results in the buildup of excess connective tissue (fibrosis), which found underneath the skin and surrounding internal organs. The degree and seriousness of the condition depends upon the type of scleroderma that the patient has. Systematic sclerosis (SSC) involves both skin and internal organs. Symptoms include thickening of the skin, the buildup of hard lumps of calcium under the skin (which can lead to infection and ulceration) and Raynaud’s phenomenon, a circulation problem that causes fingers and toes to turn white in the cold. Organs affected can include the heart, esophagus (food pipe), kidneys and intestines. These can lead to, among other things, shortness of breath, high blood pressure and diarrhea. Treatment options are limited, at the moment, and the prognosis for patients with severe skin and organ involvement is poor; they typically have a 10 year survival rate of less than 40%. The cause of the disease is unknown, but it is believed that the activation of platelets (blood cells that causes clots when we bleed) and resulting production of a chemical called serotonin may lead to tissue fibrosis. A recent study has shown that stopping platelet aggregation (the first step in platelet activation) using a drug called clopidogrel (an antiplatelet) leads to a reduction in fibrosis in laboratory mice. Here, we want to see if clopidogrel can help people with SSC, by reducing the amount of serotonin produced and therefore, fibrosis.
Who can participate?
Patients over 18 that have been diagnosed with scleroderma.
What does the study involve?
First of all, all participants undergo an extensive laboratory and clinical assessment which includes a review of their medical history, basic blood and urine laboratory tests, tests to check how well their lungs and heart are working and overall assessment of severity of disease. They are then given 75mg of clopidogrel, once a day for 12 months. During this time, the participants are given further clinical assessments and blood tests every three months to see how their disease is progressing.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital of Patras (Greece)
When is the study starting and how long is it expected to run for?
December 2913 to December 2014
Who is funding the study?
University of Patras (Greece)
Who is the main contact?
Dr Dimitris Daoussis
jimdaoussis@hotmail.com
Study website
Contact information
Type
Scientific
Contact name
Dr Dimitris Daoussis
ORCID ID
Contact details
University Hospital of Patras
Medical School
Rheumatology Department
Patras
26500
Greece
+30 (0)2613603693
jimdaoussis@hotmail.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clopidogrel in systemic sclerosis: an open labelled, proof of concept study
Acronym
N/A
Study hypothesis
The aim of this proof of concept, open label study is to assess whether clopidogrel, a strong inhibitor of platelet activation, can favorably affect fibrosis in patients with systemic sclerosis potentially by reducing the production of serotonin, a pivotal mediator of fibrosis.
Ethics approval(s)
University Hospital of Patras Ethics Committee, 19/10/2013, ref. 8524
Study design
Single-center open-label uncontrolled proof-of-concept study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Systemic Sclerosis/Rheumatology
Intervention
Treatment with Clopidogrel 75mg PO daily for 1 year
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Primary outcome measure
Patients will be assessed after 1 year of treatment.
1. Improvement of FVC and/or DLco more than 10%
2. Improvement of MRSS skin score more than 20%
Secondary outcome measures
1. Improvement of laboratory endothelial markers(s-VCAM & s-ICAM)
2. Reduction in serotonin levels in platelet poor plasma
Overall study start date
05/12/2013
Overall study end date
05/12/2014
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Scleroderma diagnosis based on 2012 ACR/EULAR classification criteria
2. Age over 18
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
20
Participant exclusion criteria
1. History of endocranial bleeding
2. History of gastrointestinal ulcer
3. Renal failure,EGFR less than 30ml/min based on MDRD formula
Recruitment start date
05/12/2013
Recruitment end date
05/12/2014
Locations
Countries of recruitment
Greece
Study participating centre
University Hospital of Patras
Patras
26500
Greece
Sponsor information
Organisation
University of Patras Research Committee (ELKE)
Sponsor details
University of Patras Campus
Rion
Patras
26500
Greece
+30 (0)2610 96 9058
dep_rector_res@upatras.gr
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
University of Patras, Medical School Research Committee (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/05/2016 | Yes | No |