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
  Purpose

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.


Condition Intervention Phase
Vasospastic Syndrome
Drug: Triflusal
Drug: Aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Enrollment: 92
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Disgren
Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
Drug: Triflusal
Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
Other Name: Disgren®
Experimental: Aspirin
Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
Drug: Aspirin
Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
Other Name: Astrix

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612273

Locations
Korea, Republic of
Division of Cardiology, Department of Internal Medicine, severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01612273     History of Changes
Other Study ID Numbers: 4-2011-0018
Study First Received: May 31, 2012
Last Updated: March 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Vasospastic syndrome
Vascular dysregulation

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Triflusal
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014