The Effect of Triflusal on Peripheral Microcirculation Dysfunction

Study Overview
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Brief Summary
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To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation dysfunction. Triflusal is a salicylate compound approved in several countries as antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to explore if there is a improvement of peripheral microcirculation by triflusal.

Official Title
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The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.

Conditions
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Vasospastic Syndrome

Intervention / Treatment
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* Drug: Triflusal
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 40 and 70 years of age Diagnosed vasospastic syndrome with nailfold capillaroscopy (Fingertip is subjected to carbon dioxide at -15°C for 60 seconds. People found to have a blood-flow standstill of at least 12s in one or more capillaries were defined as having vasospasticity) More than seven points in 10-question interview provided by Nagashima et al. Written informed consent Exclusion Criteria: Prior documented diabetes Overt peripheral artery disease Pregnant or nursing bleeding tendency Any contraindication of antiplatelet agent Thrombocytopenia (platelet < 100,000mm3) Chronic liver disease (ALT > 100 IU/L or AST > 100 IU/L) or renal dysfunction (creatinine > 4.0 mg/dl) Patients who can not stop to take aspirin

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disgren<br>Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design. | Drug: Triflusal<br>* Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.<br>* Other names: Disgren®;|
| Experimental: Aspirin<br>Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design. | Drug: Aspirin<br>* Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.<br>* Other names: Astrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire. | Comparison of the PSV (peak systolic velocity) and EDV (end diastolic velocity) measured by finger doppler ultrasonography between disgren and aspirin groups after 6 weeks treatment. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasospastic syndrome, Vascular dysregulation