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Study Status: 
Open
Study Description: 

AMYLOID

Study Name: ION-682884-CS2 (Amyloid)

Study Objective: A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled

Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Key Inclusion Criteria:

  • Medical history of HF secondary to hereditary or wild-type ATTR-CM with at least:

A) prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker/ICD (implantable cardioverter defibrillator) placement, OR

B) symptoms and signs of volume overload or elevated intracardiac pressure that either requires or required treatment with diuretics for clinical stabilization

  • End-diastolic interventricular septum thickness of > 12 mm on screening echocardiogram
  • Screening NT-proBNP ≥ 600 pg/mL by central lab. 4. New York Heart Association (NYHA) class I-III
  • 6MWT ≥ 150 meters

 Key Exclusion Criteria:

  • Hospitalization or urgent visit to ER/ED for worsening of HF with discharge date within

4 weeks prior to or during Screening

  • Uncontrolled hypertension SBP > 160 or  DBP > 100 mmHg
  • Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated  liver transplant or LVAD within 1 year after randomization
  •  Active infection requiring systemic antiviral or antimicrobial therapy that will not be   

               completed prior to Study Day 1

  • Known history of or positive test for human immunodeficiency virus (HIV)
Principal Investigator: 
Parag Goyal, MD
Contact: 

PI: Parag Goyal, MD (646) 962 5555

RC:  Astrid Carmona   (212) 746 2623

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