A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)

Roche

Status and phase: Completed; Phase 3

Conditions: Coronary Heart Disease

Treatments: Drug: dalcetrapib; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323153

WC25501

Details and patient eligibility

About

This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.

Enrollment: 300 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/=45 years of age
• Patients admitted to the hospital for acute coronary syndrome (ACS)
• Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion criteria

• Symptomatic congestive heart failure (NYHA Class III or IV)
• Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
• Uncontrolled hypertension
• Uncontrolled diabetes
• Severe anemia
• Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Dalcetrapib

Experimental group

Treatment:

Drug: dalcetrapib

Placebo

Placebo Comparator group

Treatment:

Drug: placebo