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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Vasospastic Syndrome Drug: Triflusal Drug: Aspirin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.
Study Start Date : April 2011
Primary Completion Date : January 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01612273     History of Changes
Other Study ID Numbers: 4-2011-0018
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Yonsei University:
Vasospastic syndrome
Vascular dysregulation

Additional relevant MeSH terms:
Aspirin
Salicylates
Triflusal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics