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The Effect of Triflusal on Peripheral Microcirculation Dysfunction

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Yonsei University

Status and phase

Completed
Phase 4

Conditions

Vasospastic Syndrome

Treatments

Drug: Aspirin
Drug: Triflusal

Study type

Interventional

Funder types

Other

Identifiers

NCT01612273
4-2011-0018

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

92 participants in 2 patient groups

Disgren
Experimental group
Description:
Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
Treatment:
Drug: Triflusal
Aspirin
Experimental group
Description:
Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
Treatment:
Drug: Aspirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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