The Effect of Triflusal on Peripheral Microcirculation Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Vasospastic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Disgren

Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.

Group Type EXPERIMENTAL

Triflusal

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.

Interventions

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Triflusal

Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.

Intervention Type DRUG

Aspirin

Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.

Intervention Type DRUG

Other Intervention Names

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Disgren® Astrix

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No