Primary Raynaud's Phenomenon and Systemic Sclerosis MedDRA version: 12.1 Level: LLT Classification code 10042953 Term: Systemic Sclerosis MedDRA version: 12.0 Level: LLT Classification code 10037917 Term: Raynaud's phenomenon
Conditions
Interventions
Trade Name: Asasantin Retard ®
Product Name: ASASANTIN Retard
Pharmaceutical Form: Capsule*
INN or Proposed INN: aspirin
CAS Number: 50-
Sponsors
Royal National Hospital for Rheumatic Disease
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Systemic Sclerosis (fulfilling ARA criteria) or Primary Raynaud's Phenomenon (defined as at least 2 episodes of fingertip localized notable blue and/or sequential blue and white discoloration, in conjunction with pain upon cold exposure or emotional stress within the one week of examination in the absence of other features of connective tissue disease. 18 to 75 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects shall be excluded from all aspects of the study if: 1) pregnant or breastfeeding (women of child bearing age will be required to practice a medically acceptable method of birth control throughout the study period) 2) surgical sympathectomy performed in the last 12 months 3) Administration of new medications used for the treatment of Raynaud's phenomenon or systemic sclerosis in the 2 months preceding, or during, the trial period. 4) Vasodilators used for the treatment of hypertension must be maintained at a constant dose throughout the study period. 5) Administration of a selective serotonin reuptake inhibitor in the 2 months preceding or during the study period. 6) Refusal by participants for their General Practitioner to be informed of inclusion in the study Subjects shall remain eligible for the first part of the study but shall be excluded from participation in the second stage of the study if they are: 1) current use of aspirin, dipyridamole or alternative antiplatelet agent 2) primary bleeding diathesis or platelet disorder 3) anticoagulation with warfarin 4) history of peptic or duodenal ulceration 5) history of intolerance or allergy to aspirin, dipyridamole or other nonsteroidal anti-inflammatory medications 6) Current use of oral corticosteroids and/or non-steroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: An explorative study investigating the potential therapeutic effects of asasantin retard in patients with primary Raynaud's phenomenon and systemic sclerosis through assessment of treatment effects on: 1) the clinical severity of Raynaud's phenomenon 2) the finger blood flow response to cold stress test (assessed using thermal and laser speckle imaging) 3) Platelet function testing assessed using aggregometry 4) blood markers of platelet activation and endothelial damage 5) level of oxidative stress ;Primary end point(s): The Raynaud's Condition Score (RCS) in patients with primary Raynaud's phenomenon and systemic sclerosis, before and during 2 weeks treatment with asasantin retard.; Secondary Objective: 1) Assessment of the reproducibility of the cold challenge test assessed using thermal imaging and laser contrast speckle imaging in patients with primary Raynaud's phenomenon and systemic sclerosis. 2) Assessment of the "validity" of a series of biomarkers of platelet activation and aggregometry in predicting subtype and severity of disease, in patients with primary Raynaud's phenomenon and systemic sclerosis i.e. do levels of these markers correlate with disease type and severity in patients with Raynaud's phenomenon and systemic sclerosis. 3) Comparison between platelet function in PRP vs SSc and response to asasantin retard therapy. 4) Assessment of markers of oxidative stress in patients with primary Raynaud's and systemic sclerosis and the potential therpeutic effects of asasantin retard therapy | — |
Countries
United Kingdom
Outcome results
None listed