Clopidogrel in systemic sclerosis

ISRCTN	ISRCTN63206606
DOI	https://doi.org/10.1186/ISRCTN63206606
Protocol serial number	N/A
Sponsor	University of Patras Research Committee (ELKE)
Funder	University of Patras, Medical School Research Committee (Greece)

Submission date: 22/10/2014
Registration date: 02/12/2014
Last edited: 23/02/2018

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Dimitris Daoussis
Scientific

University Hospital of Patras
Medical School
Rheumatology Department
Patras
26500
Greece

Phone	+30 (0)2613603693
Email	jimdaoussis@hotmail.com

Study information

Primary study design	Interventional
Study design	Single-center open-label uncontrolled proof-of-concept study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Clopidogrel in systemic sclerosis: an open labelled, proof of concept study
Study acronym	N/A
Study objectives	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
Health condition(s) or problem(s) studied	Systemic Sclerosis/Rheumatology
Intervention	Treatment with Clopidogrel 75mg PO daily for 1 year
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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%
Key secondary outcome measure(s)	1. Improvement of laboratory endothelial markers(s-VCAM & s-ICAM) 2. Reduction in serotonin levels in platelet poor plasma
Completion date	05/12/2014
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Scleroderma diagnosis based on 2012 ACR/EULAR classification criteria 2. Age over 18
Key exclusion criteria	1. History of endocranial bleeding 2. History of gastrointestinal ulcer 3. Renal failure,EGFR less than 30ml/min based on MDRD formula
Date of first enrolment	05/12/2013
Date of final enrolment	05/12/2014

Locations

Countries of recruitment

Greece

Study participating centre

University Hospital of Patras

Patras
26500
Greece

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	17/05/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/02/2018: Publication reference added.