The Effect of Triflusal on Peripheral Microcirculation Dysfunction
This study is currently recruiting participants.
Verified May 2012 by Yonsei University
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01612273
First received: May 31, 2012
Last updated: June 4, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vasospastic Syndrome |
Drug: Triflusal Drug: Aspirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study. |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 110 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Astrix
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612273
Contacts
| Contact: Hyuk-Jae Chang, MD, PhD | 82-2-2228-8454 | hjchang@yuhs.ac |
Locations
| Korea, Republic of | |
| Division of Cardiology, Department of Internal Medicine, severance hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Hyuk-Jae Chang, MD 2-2-2228-8454 hjchang@yuhs.ac | |
| Principal Investigator: Hyuk-Jae Chang, MD | |
Sponsors and Collaborators
Yonsei University
More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01612273 History of Changes |
| Other Study ID Numbers: | 4-2011-0018 |
| Study First Received: | May 31, 2012 |
| Last Updated: | June 4, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Yonsei University:
|
Vasospastic syndrome Vascular dysregulation |
Additional relevant MeSH terms:
|
Aspirin Triflusal Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013