Research Study: PROMINENT
Condition:
Type 2 diabetes
Study Sponsor: Kowa Research Institute
Study Investigator: Mathew Chu, MD
Study Contact: Ezi Ebere
Ezinwanyi.UbaniEbere@allina.com
612-863-4393
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

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 Cardiovascular (CV) death.
Eligibility Criteria:

  • 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)
  • HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
  • 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
    • Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
    • 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)

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!