Condition category
Skin and Connective Tissue Diseases
Date applied
22/10/2014
Date assigned
02/12/2014
Last edited
06/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

05/12/2013

Overall trial end date

05/12/2014

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

1. Scleroderma diagnosis based on 2012 ACR/EULAR classification criteria
2. Age over 18

Participant type

Patient

Age group

Adult

Gender

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

Trial 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

http://research.upatras.gr

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes