Asasantin retard therapy in the management of Raynaud's phenomenon

• Research type

  Research Study

• Full title

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

• IRAS ID

  26382

• Sponsor organisation

  Royal National Hospital for Rheumatic Diseases

• Eudract number

  2009-013468-37

• ISRCTN Number

  Not applicable

• Research summary

  Raynaud's phenomenon is the inappropriate constriction of blood vessels in response to exposure to cold or emotional stress. It can occur in healthy people (primary Raynaud's phenonmenon) but sometimes heralds the development of potentially life threatening diseases such as systemic sclerosis. Platelets are white blood cells whose main function is to stop bleeding through clot formation. There is compelling evidence that platelets contribute to the development of Raynaud's phenomenon, particularly in systemic sclerosis. Insufficient work has been undertaken to assess the potentially therapeutic effects of antiplatelet agents in the management of Raynaud's phenomenon. We have designed a pilot study to assess the short term effects of asasantin retard (aspirin and dipyridamole in combination) on the severity of Raynaud's phenomenon, finger blood flow, blood stream markers of platelet activity and oxidative stress in patients with either primary Raynaud's phenomenon or Systemic Sclerosis. The study will be undertaken at the Royal National Hospital for Rheumatic Diseases (RNHRD). The study will last 4 weeks and participants will attend the clinical measurement department of RNHRD for 3 assessments. The initial 2 weeks will be a "run-in" period, during which time participants will keep a diary of the frequency and severity of their Raynaud's attacks. Participants will then take asasantin retard (2 tablets per day) for the second 2 weeks. Assessment of Raynaud's severity, digital microvascular function, levels of oxidative stress and blood stream markers of platelet activation will take place after the initial "run-in" period, and again after the 2 weeks treatment with asasantin retard. This work will further our understanding of the role platelets play in Raynaud's phenomenon, with the potential to open up a new therapeutic avenue in the management of Raynaud's phenomenon. The study will contribute to the development of a new assessment tool, for use in future studies of Raynaud's phenomenon.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/69

• Date of REC Opinion

  29 Sep 2010

• REC opinion

  Favourable Opinion