A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomenon

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2009-013468-37-GB
• Date of registration: 17/03/2010
• Prospective Registration: Yes
• Primary sponsor: Royal National Hospital for Rheumatic Disease
• Public title: A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomenon
• Scientific title: A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon. - Asasantin retard therapy in the management of Raynaud's phenomenon
• Date of first enrolment: 29/09/2010
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013468-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: Open: yes; Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: No treatment run-in phase.
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Asasantin Retard ®
Product Name: ASASANTIN Retard
Pharmaceutical Form: Capsule*
INN or Proposed INN: aspirin
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: dipyridamole
CAS Number: 58-32-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

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

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 ID(s)

Protocol code BA7

Not applicable

Ethics review

Status: Approved
Approval date:
Contact: