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The Effect of Triflusal on Peripheral Microcirculation Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01612273
First received: May 31, 2012
Last updated: March 4, 2014
Last verified: March 2014

May 31, 2012
March 4, 2014
April 2011
January 2013   (final data collection date for primary outcome measure)
Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01612273 on ClinicalTrials.gov Archive Site
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The Effect of Triflusal on Peripheral Microcirculation Dysfunction
The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vasospastic Syndrome
  • Drug: Triflusal
    Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
    Other Name: Disgren®
  • Drug: Aspirin
    Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
    Other Name: Astrix
  • Experimental: Disgren
    Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
    Intervention: Drug: Triflusal
  • Experimental: Aspirin
    Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
    Intervention: Drug: Aspirin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01612273
4-2011-0018
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP