The Effect of Triflusal on Peripheral Microcirculation Dysfunction

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612273

Enrollment

Registered

2012-06-05

Start date

2011-04-30

Completion date

2013-06-30

Last updated

2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasospastic Syndrome

Keywords

Vasospastic syndrome, Vascular dysregulation

Brief summary

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.

Interventions

DRUGTriflusal

Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.

DRUGAspirin

Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire.	6 weeks	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026