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.

Study Overview

• Status: Completed
• Conditions: Vasospastic Syndrome
• Intervention / Treatment: Drug: Triflusal; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Division of Cardiology, Department of Internal Medicine, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Astrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Vasospastic syndrome; Vascular dysregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin; Triflusal
• Other Study ID Numbers: 4-2011-0018