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Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) (PROMINENT)

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ClinicalTrials.gov Identifier: NCT03071692
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE February 23, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE March 23, 2017
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Number of patients with first occurrence of nonfatal MI, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or CV death. [ Time Frame: Through study completion, an average of 4 years ]
Number of patients with first occurrence of nonfatal MI, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or CV death.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03071692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Time to first occurrence of any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death
  • Time to first occurrence of any component of the primary endpoint or hospitalization for Heart failure (HF) [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint or hospitalization for Heart failure (HF)
  • Time to first occurrence of any component of the primary endpoint or all-cause mortality [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint or all-cause mortality
  • Time to first occurrence of any component of the primary endpoint, any coronary revascularization, or hospitalization for HF [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint, any coronary revascularization, or hospitalization for HF
  • Time to first occurrence of any new or worsening Peripheral artery disease (PAD) [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study)
  • Lipid Endpoints [ Time Frame: Week -3 to Month 4 (Visit 1 to Visit 5) ]
    The change from Screening/Enrollment Visit (Visit 1) to Month 4 Visit (Visit 5) for the following lipid biomarkers: Total cholesterol (TC), Triglyceride(s) (TG), High-density lipoprotein cholesterol (HDL-C), non-HDL-C (calculated), Very low-density lipoprotein cholesterol (VLDL-C) (calculated), ApoA1, ApoC3, and ApoE
  • Nonfasting Remnant Cholesterol Endpoint [ Time Frame: Week 0 to Month 6 (Visit 2 to Visit 6) ]
    The change from Randomization Visit (Visit 2) to Month 6 Visit (Visit 6) for nonfasting remnant cholesterol
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Time to first occurrence of any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the 3-component composite endpoint of non-fatal MI, non-fatal stroke, or cardiovascular death
  • Time to first occurrence of any component of the primary endpoint or hospitalization for Heart failure (HF) [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint or hospitalization for Heart failure (HF)
  • Time to first occurrence of any component of the primary endpoint or all-cause mortality [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint or all-cause mortality
  • Time to first occurrence of any component of the primary endpoint, any coronary revascularization, or hospitalization for HF [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any component of the primary endpoint, any coronary revascularization, or hospitalization for HF
  • Time to first occurrence of any new or worsening Peripheral artery disease (PAD) [ Time Frame: Through study completion, an average of 4 years ]
    Time to first occurrence of: Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study)
  • Lipid Endpoints [ Time Frame: Week -3 to Month 4 (Visit 1 to Visit 5) ]
    The change from Screening/Enrollment Visit (Visit 1) to Month 4 Visit (Visit 5) for the following lipid biomarkers: Total cholesterol (TC), Triglyceride(s) (TG), High-density lipoprotein cholesterol (HDL-C), non-HDL-C (calculated), Very low-density lipoprotein cholesterol (VLDL-C) (calculated), ApoA1, ApoC3, and ApoE
  • Nonfasting Remnant Cholesterol Enpoint [ Time Frame: Week 0 to Month 6 (Visit 2 to Visit 6) ]
    The change from Randomization Visit (Visit 2) to Month 6 Visit (Visit 6) for nonfasting remnant cholesterol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Official Title  ICMJE Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Brief Summary

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

  • nonfatal Myocardial Infarction (MI)
  • nonfatal ischemic stroke
  • hospitalization for unstable angina requiring unplanned coronary revascularization; or
  • Cardio Vascular (CV) death.
Detailed Description

A multi-regional clinical trial with participating sites planned in the following countries pending approval from the applicable oversight authorities:

  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czech Republic
  • Denmark
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Russian Federation
  • Slovakia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom
  • United States
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Type2 Diabetes
  • Dyslipidemia
Intervention  ICMJE
  • Drug: K-877
    0.2mg tablet
    Other Name: pemafibrate
  • Drug: Placebo
    K-877 matching placebo tablet
Study Arms  ICMJE
  • Experimental: Treatment Group
    K-877 (pemafibrate) tablet twice daily.
    Intervention: Drug: K-877
  • Placebo Comparator: Control Group
    Matching K-877 placebo tablet twice daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
10000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  2. HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either

    1. Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
    2. Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:

      • i. Prior MI or ischemic (non-hemorrhagic) stroke
      • ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
      • iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
      • iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
      • v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing [eg, toe-brachial index, angiogram, or other imaging study])
      • vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

Exclusion Criteria:

  1. Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
  2. Known sensitivity to PPAR-α agonists or tablet excipients
  3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin > 100 mg/day or dietary supplements or prescription omega-3 fatty acids > 1 g/day
  4. Type 1 diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Senior Clinical Research Associate 919-433-1600 Clinical@KowaUS.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Japan,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071692
Other Study ID Numbers  ICMJE K-877-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kowa Research Institute, Inc.
Study Sponsor  ICMJE Kowa Research Institute, Inc.
Collaborators  ICMJE Brigham and Women's Hospital
Investigators  ICMJE
Study Director: Paul Ridker, MD CCVDP & The Brigham and Women's Hospital
Study Director: Aruna Pradhan, MD CCVDP & The Brigham and Women's Hospital
PRS Account Kowa Research Institute, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP