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The Effect of Triflusal on Peripheral Microcirculation Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01612273
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE May 31, 2012
First Posted Date  ICMJE June 5, 2012
Last Update Posted Date March 5, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Triflusal on Peripheral Microcirculation Dysfunction
Official Title  ICMJE The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vasospastic Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
92
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
110
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01612273
Other Study ID Numbers  ICMJE 4-2011-0018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date March 2014

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