Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator (TEMPO)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Ventricular Arrhythmia

Treatments: Drug: Eleclazine; Drug: Placebo to match eleclazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02104583

2013-004430-15 (EudraCT Number)

GS-US-356-0101

Details and patient eligibility

About

The primary objective of this study is to evaluate the effect of eleclazine (GS-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).

Enrollment: 313 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have an ICD or CRT-D implanted for primary or secondary prevention and at least one ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to implantation) within 60 days prior to screening
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Must be hemodynamically stable

Key Exclusion Criteria:

• New York Heart Association (NYHA) Class IV heart failure
• Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during the screening period before randomization
• Hemodynamically significant primary obstructive valvular disease
• History of congenital heart disease
• Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.
• Individuals who are being considered for cardiac transplantation and are on a cardiac transplant list
• History of seizures or epilepsy
• Cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study
• Severe renal impairment
• Abnormal liver function tests
• Currently taking Class I and Class III antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization
• Currently taking drugs or products that are strong inhibitors or inducers of CYP3A; such medications should be discontinued 5 half-lives prior to randomization
• Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization
• Females who are pregnant or are breastfeeding
• Individuals with a subcutaneous ICD
• Body mass index (BMI) ≥ 36 kg/m^2

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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313 participants in 3 patient groups, including a placebo group

Eleclazine 3 mg

Experimental group

Description:

Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months.

Treatment:

Drug: Eleclazine

Eleclazine 6 mg

Experimental group

Description:

Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months.

Treatment:

Drug: Eleclazine

Placebo

Placebo Comparator group

Description:

Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.

Treatment:

Drug: Placebo to match eleclazine