The Effect of Triflusal on Peripheral Microcirculation Dysfunction

Phase 4

Completed

• Conditions: Vasospastic Syndrome
• Interventions: Drug: Aspirin; Drug: Triflusal

• Registration Number: NCT01612273
• Lead Sponsor: Yonsei University

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 available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire.	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.

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, severance hospital; 🇰🇷 Seoul, Korea, Republic of