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Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy

Not Applicable
Conditions
Hyperuricemia
Interventions
Registration Number
NCT01984749
Lead Sponsor
Freed Study Group
Brief Summary

The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for cerebral and cardiorenovascular disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
1000
Inclusion Criteria
  • (1) Patients 65 years of age or older at enrollment who are able to visit
  • (2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment
  • (3) Patients at risk for any of the cerebral or cardiorenovascular diseases in i) through iv) below (i) Previous or current history of hypertension (ii) Previous or current history of type 2 diabetes mellitus (iii) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) (iv) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure)
  • (4) Patients who personally give written informed consent to participate in this study
Exclusion Criteria
  • (1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment
  • (2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol
  • (3) Patients with malignant tumors
  • (4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2 , etc.
  • (5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage)
  • (6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment
  • (7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment
  • (8) Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal within 3 months prior to enrollment
  • (9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine
  • (10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat
  • (11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics
  • (12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products)
  • (13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded)
  • (14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Febuxostat treatment groupFebuxostatOnce daily after breakfast (generally within 30 minutes after eating)
Primary Outcome Measures
NameTimeMethod
Development of cerebral or cardiorenovascular events and all deathsEnrollment through Month 36

Definition of "cerebral and cardiorenovascular events":

1. Death due to cerebral or cardiorenovascular disease

2. New or recurrent cerebrovascular disease (stroke \[cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, stroke of unknown type\], transient ischemic attack

3. New or recurrent non-fatal coronary artery disease (myocardial infarction and unstable angina pectoris)

4. Cardiac failure requiring hospitalization

5. Arteriosclerotic disease requiring hospitalization (aortic aneurysm, aortic dissection, and arteriosclerosis obliterans)

6. Renal impairment (development of microalbuminuria, progression to overt proteinuria, or overt proteinuria \[≥ 300 mg/gCr\], confirmed by two consecutive laboratory tests performed after the initiation of study treatments; doubling of serum creatinine level; and progression to ESRD)

7. New atrial fibrillation (including paroxysmal atrial fibrillation)

8. Deaths that are not caused by cerebral or cardiorenovascular disease

Secondary Outcome Measures
NameTimeMethod
Occurrence of cerebral or cardiorenovascular event by prior history of cerebral or cardiorenovascular diseaseEnrollment through Month 36
Amount of change and percent change in serum uric acid levelEnrollment through Month 36 (or withdrawal from the study)
Estimated glomerular filtration rate (eGFR)Enrollment, 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Blood pressure (systolic/diastolic)Enrollment, 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat doseEnrollment through Month 36
Amount of change and percent change in quantified urinary proteinEnrollment through Month 24
Occurrence of cerebral or cardiorenovascular event by eventEnrollment through Month 36
Occurrence of cerebral or cardiorenovascular event by serum uric acid levelEnrollment through Month 36
Serum uric acid levelAt screening, at enrollment, at 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or at withdrawal from the study)
Change in serum uric acid levelEnrollment through Week 4
Amount of change and percent change in eGFREnrollment through Month 36 (or withdrawal from the study)
Amount of change and percent change in quantitative urinary proteinEnrollment through Month 36 (or withdrawal from the study)
Urine microalbumin-creatinine ratioEnrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Occurrence of adverse eventsEnrollment through Month 36
Percent Achieving serum uric acid level of 6.0mg/dLEnrollment to completion of study or withdrawal
Amount of change and percent change in urine microalbumin-creatinine ratioEnrollment through Month 36 (or withdrawal from the study)
Quantification of urinary proteinEnrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Amount of change and percent change in blood pressure (systolic/diastolic)Enrollment through Month 36 (or withdrawal from the study)
Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinolEnrollment through Month 36

Trial Locations

Locations (139)

Hiramitsu Heart Clinic

🇯🇵

Nagoya, Aichi, Japan

Ogawa-naika Clinic

🇯🇵

Nagoya, Aichi, Japan

Shakaiiryohojin Kojunkai Daido Hospital

🇯🇵

Nagoya, Aichi, Japan

Honjo Daiichi Hospital

🇯🇵

Yurihonjo, Akita, Japan

Iriyouhoujin Siyadan Yanagisawakai Yanagisawaiin

🇯🇵

Matsudo, Chiba, Japan

Matsuno Medical Clinic

🇯🇵

Iyo-gun, Ehime, Japan

Ishite Matsumoto Naika Junkanki Clinic

🇯🇵

Matsuyama, Ehime, Japan

Ehime Medical CO-OP Izumigawa Clinic

🇯🇵

Niihama, Ehime, Japan

Hanaoka IC Clinic

🇯🇵

Buzen, Fukuoka, Japan

Otonari Clinic

🇯🇵

Chikushino, Fukuoka, Japan

Scroll for more (129 remaining)
Hiramitsu Heart Clinic
🇯🇵Nagoya, Aichi, Japan

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