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Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Comorbidities (CARES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Teijin America, Inc.
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01101035
First received: April 7, 2010
Last updated: August 17, 2016
Last verified: August 2016
  Purpose

The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events). Examples of major cardiovascular events include heart attacks, strokes, and angina (chest pain due to narrowing of the blood vessels of the heart) that need to be treated urgently with a heart operation. The overall duration of the study is dependent on the number of predefined major cardiovascular events (MACE). The length of study is expected to be approximately 9 years in order to observe the required 624 MACE. The length of study participation for each subject will vary due to the event driven study design.

The purpose of this study is to see if subjects with gout who receive febuxostat or allopurinol, once daily (QD), have a higher rate of serious heart and blood vessel complications.


Condition Intervention Phase
Cardiovascular Disease
Drug: Febuxostat
Drug: Allopurinol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • First occurrence of any event in the predefined Major Adverse Cardiovascular Events Composite. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of any event in the predefined Major Adverse Cardiovascular Events (MACE) Composite, which includes: Cardiovascular death, Non-fatal Myocardial Infarction, Nonfatal Stroke and Unstable Angina with Urgent Coronary Revascularization.


Secondary Outcome Measures:
  • First occurrence of any Antiplatelet Trialists' Collaborative Event. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of any Antiplatelet Trialists' Collaborative Event, which includes Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke.

  • First occurrence of Cardiovascular Death death. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Cardiovascular Death.

  • First occurrence of Non-fatal Myocardial Infarction. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of nonfatal Myocardial Infarction.

  • First occurrence of Non-fatal stroke. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Non-fatal Stroke.

  • First occurrence of Unstable Angina with Urgent Coronary Revascularization. [ Time Frame: At first occurrence (up to 60 Months) ] [ Designated as safety issue: Yes ]
    The time from randomization to the first occurrence of Unstable Angina with Urgent Coronary Revascularization.


Enrollment: 6198
Study Start Date: April 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Febuxostat 40 mg or 80 mg QD
(dependent on serum uric acid levels)
Drug: Febuxostat
Febuxostat 40 mg or 80 mg (depending on serum uric acid levels), capsules, orally, once daily for up to 60 months.
Other Names:
  • Uloric
  • TMX-67
Active Comparator: Allopurinol 200 mg to 600 mg QD
(dependent on renal function)
Drug: Allopurinol
Allopurinol 200 mg to 600 mg (depending on renal function), capsules, orally, once daily for up to 60 months.
Other Names:
  • Zyloprim
  • Allohexal
  • Allosig
  • Milurit
  • Alloril
  • Progout
  • Zyloric
  • Puricos
  • Zyrik 300
  • Aluron

Detailed Description:

This is a phase 3B multicenter, randomized, double-blind, active-controlled study designed to evaluate the cardiovascular (CV) safety of febuxostat compared with allopurinol in subjects with gout and significant CV comorbidities. Approximately 7500 subjects, males 50 years of age or older or females 55 years of age or older (at least 2-years post-menopausal), with gout and health problems affecting the heart or blood vessels will take part in this study at approximately 450 study centers in North America.

This study will use competitive enrollment. This means that when a target number of subjects has entered the treatment phase of the study, all further screening of subjects will be closed. The length of the study is based on an ongoing review of study results. The participation will last a maximum of 9 years and will include a maximum 28 visits to the study center. Telephone contact will be made every 2 months for subjects who have discontinued the study drug for any reason, but who are asked to continue in the study to be followed for potential cardiovascular events. This study design is called a "Time to Event Study". All study subjects will continue to be followed until enough information has been gathered to determine the overall safety of the study drug.

Gout is caused by high levels of uric acid in the body, and is associated with a broad range of conditions including heart disease, chronic kidney disease and additional risk factors like obesity and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form from supersaturated body fluids and settle in joints and other organs.

People with gout may also have a higher incidence of other conditions that may be associated with hyperuricemia, gout or both. This is supported by a growing body of research demonstrating that serum urate levels are an independent predictive factor for cardiovascular disease when the effects of other risk factors have been controlled.

This study will explore the cardiovascular safety of febuxostat to determine whether the use of febuxostat is associated with a moderate increase in the risk of serious adverse cardiovascular outcomes as compared to allopurinol.

Participation will last a maximum of 5 years and will include 15 to 20 visits to the study center.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject or the subject's legally acceptable representative signs and dates a written, informed consent form/Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to the initiation of any study procedures.
  2. The subject is male ≥50 years of age or female ≥55 years of age and at least 2-years post-menopausal.
  3. The subject has a history of major CV or cerebrovascular disease including at least one of the following:

    • MI.
    • Hospitalized unstable angina.
    • Cardiac or cerebrovascular revascularization procedure.
    • Stroke.
    • Hospitalized TIA.
    • Peripheral vascular disease (ankle brachial index ≤0.6, revascularization and/or well-documented history of claudication).
    • History of diabetes mellitus with evidence of micro- or macrovascular disease (retinopathy, neuropathy, nephropathy, small vessel vascular diseases).
  4. The subject has a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout:

    • A tophus proven to contain urate crystals by chemical or polarized light microscopic means, and/or
    • Characteristic urate crystals in the joint fluid, and/or
    • History of at least 6 of the following clinical, laboratory, and x-ray phenomena:

      • More than 1 attack of acute arthritis.
      • Maximum inflammation developed within 1 day.
      • Monoarticular arthritis.
      • Redness observed over joints.
      • First metatarsophalangeal joint painful or swollen.
      • Unilateral first metatarsophalangeal joint attack.
      • Unilateral tarsal joint attack.
      • Tophus (proven or suspected).
      • Hyperuricemia.
      • Asymmetric swelling within a joint on x-ray.
      • Subcortical cysts without erosions on x-ray.
      • Joint fluid culture negative for organisms during attack.
  5. The subjects must have either:

    • a sUA level ≥7.0 mg/dL (≥416 μmol/L) at the Day -7 Visit OR
    • a sUA level ≥6.0 mg/dL (≥354 μmol/L) at the Day -7 Visit AND inadequately controlled gout (≥1 flare in the 12 months prior to screening and/or the presence of tophi).
  6. The subject is capable of understanding and complying with protocol requirements

Exclusion Criteria:

Subjects who meet any of the following criteria will not qualify for entry into this study:

  1. The subject has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ transplant).
  2. The subject has a history of xanthinuria.
  3. The subject has received urate-lowering therapy (i.e., febuxostat, allopurinol, probenecid, etc.) or excluded medication during the screening period (beginning with Day -7).
  4. The subject has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation.
  5. The subject has active peptic ulcer disease.
  6. The subject has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the first dose of study medication.
  7. The subject had MI or stroke within 60 days prior to the Screening Visit.
  8. The subject has ALT and/or AST values greater than 2 times the upper limit of normal (×ULN) during the Screening period.
  9. The subject has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
  10. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to the Screening Visit or the subject consumes >14 alcoholic beverages per week.
  11. The subject has received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study.
  12. The subject's estimated CLcr is <30 mL/min, where CLcr is calculated using the Cockcroft and Gault formula based on ideal body weight (IBW),
  13. The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  14. The subject is required to take excluded medications
  15. The subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

Inclusion Criteria:

  • Has a history of major cardiovascular or cerebrovascular disease including at least one of the following:

    • Myocardial infarction
    • Hospitalized unstable angina
    • Cardiac or cerebrovascular revascularization procedure
    • Stroke
    • Hospitalized for transient ischemic attack
    • Peripheral vascular disease
    • History of diabetes mellitus with evidence of micro- or macrovascular disease
  • Has a history or presence of gout defined as having one or more of the American Rheumatism Association criteria for the diagnosis of gout:

    • A tophus proven to contain urate crystals by chemical or polarized light microscopic means, and/or
    • Characteristic urate crystals in the joint fluid, and/or
    • History of at least 6 of the following clinical, laboratory, and x-ray phenomena:

      • More than 1 attack of acute arthritis
      • Maximum inflammation developed within 1 day
      • Monoarticular arthritis
      • Redness observed over joints
      • First metatarsophalangeal joint painful or swollen
      • Unilateral first metatarsophalangeal joint attack
      • Unilateral tarsal joint attack
      • Tophus (proven or suspected)
      • Hyperuricemia
      • Asymmetric swelling within a joint on x-ray
      • Subcortical cysts without erosions on x-ray
      • Joint fluid culture negative for organisms during attack
  • Must have either:

    • a serum urate level greater than or equal to 7.0 mg/dL at the Day -7 Visit OR
    • a serum urate level greater than or equal to 6.0 mg/dL at the Day -7 Visit AND inadequately controlled gout

Exclusion Criteria:

  • Has secondary hyperuricemia
  • Has a history of xanthinuria
  • Has received urate-lowering or excluded medication during the screening period
  • Has a known hypersensitivity to febuxostat or allopurinol or any components of their formulation
  • Has active peptic ulcer disease
  • Has a history of cancer within 5 years prior to the first dose of study medication
  • Had a myocardial infarction or stroke within 60 days prior to the Screening Visit
  • Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2 times the upper limit of normal during the Screening period
  • Has a history of drug abuse or a history of alcohol abuse within 5 years prior to the Screening Visit or the subject consumes more than14 alcoholic beverages per week
  • Has received any investigational medicinal product within the 30 days prior to the Screening Visit and throughout the study
  • Has an estimated creatinine clearance less than 30 mL/min
  • Is required to take excluded medications
  • Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101035

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Canada
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Mexico
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Tijuana, Baja California, Mexico
Mexico, DF, Mexico
Ciudad de Mexico, Distrito Federal, Mexico
Ciudad de México, Distrito Federal, Mexico
Jalisco, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Miguel Hidalgo, Distrito Federal, Mexico
Celaya, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Puerto Vallarta, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Cuernavaca, Morelos, Mexico
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Chihuahua, Mexico
Ciudad De Mexico, Mexico
Durango, Mexico
Monterrey, Mexico
Oaxaca, Mexico
Queretaro, Mexico
San Luis Potosi, Mexico
Veracruz, Mexico
Sponsors and Collaborators
Takeda
Teijin America, Inc.
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01101035     History of Changes
Other Study ID Numbers: TMX-67_301  U1111-1114-4194 
Study First Received: April 7, 2010
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
cardiovascular outcomes
heart attack
stroke
Drug Therapy
physiology
Hyperuricemia
Uric Acid

Additional relevant MeSH terms:
Cardiovascular Diseases
Febuxostat
Allopurinol
Uric Acid
Gout Suppressants
Antirheumatic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016