The Effect of Triflusal on Peripheral Microcirculation Dysfunction

Vasospastic Syndrome Clinical Trial

Official title:

The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612273
• Other study ID #: 4-2011-0018
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2012
• Last updated: March 4, 2014
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasospastic Syndrome

Intervention

Drug:
• Triflusal
Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
• Aspirin
Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No