Trial Search Results

Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Patients With Hyperlipoproteinemia(a) and Cardiovascular Disease

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in patients with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Akcea Therapeutics

Collaborator: Ionis Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: ISIS 681257
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - Clinical diagnosis of CVD defined as documented coronary artery disease, stroke, or
   peripheral artery disease

   - Lp(a) plasma level ≥ 60 mg/dL

   - Must be on standard-of-care preventative therapy for other than elevated Lp(a) CVD
   risk factors

Key Exclusion Criteria:

   - Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or
   stroke/TIA

   - Within 3 months of Screening: coronary, carotid, or peripheral arterial
   revascularization, major non-cardiac surgery, or lipoprotein apheresis

   - Heart failure New York Heart Association (NYHA) class IV

Ages Eligible for Study

18 Years - 80 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting