The Effect of Triflusal on Peripheral Microcirculation Dysfunction
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 31, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 5, 2014
March 1, 2014
1.8 years
May 31, 2012
March 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Disgren
EXPERIMENTALDose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
Aspirin
EXPERIMENTALDose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Department of Internal Medicine, severance hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2012
First Posted
June 5, 2012
Study Start
April 1, 2011
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
March 5, 2014
Record last verified: 2014-03