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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323153
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : August 6, 2018
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: dalcetrapib Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: Dalcetrapib Drug: dalcetrapib
Oral doses of 600 mg once daily for 20 weeks

Placebo Comparator: Placebo Drug: placebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Primary Outcome Measures :
  1. Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971 [ Time Frame: 4 weeks ]
  2. Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment [ Time Frame: 20 weeks ]
  3. Percent Change From Baseline in Blood Lipid Levels [ Time Frame: 20 weeks ]
  4. Percent Change From Baseline in Lipoprotein Levels [ Time Frame: 20 weeks ]
  5. Percent Change From Baseline in Apolipoprotein Levels [ Time Frame: 20 weeks ]
  6. Safety: Incidence of Adverse Events [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323153

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United States, Florida
Pensacola, Florida, United States, 32501
Pensacola, Florida, United States, 32504
United States, Michigan
Saginaw, Michigan, United States, 48602
United States, Minnesota
Saint Cloud, Minnesota, United States, 56303
United States, New York
Syracuse, New York, United States, 13210
United States, South Dakota
Rapid City, South Dakota, United States, 57701
Ceske Budejovice, Czechia, 370 87
Chrudim, Czechia, 537 25
Hradec Kralove, Czechia, 500 05
Jihlava, Czechia, 586 01
Jindrichuv Hradec, Czechia, 377 38
Praha, Czechia, 100 34
Semily, Czechia, 513 31
Teplice, Czechia, 415 01
Zlin, Czechia, 762 75
Znojmo, Czechia, 669 02
Amsterdam, Netherlands, 1091 AC
Arnhem, Netherlands, 6815 AD
Beverwijk, Netherlands, 1942 LE
Breda, Netherlands, 4818 CK
Den Helder, Netherlands, 1782GZ
Eindhoven, Netherlands, 5623 EJ
Gouda, Netherlands, 2803 HH
Heerlen, Netherlands, 6419 PC
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6532 SZ
Rotterdam, Netherlands, 3045 PM
Sneek, Netherlands, 8601 ZK
United Kingdom
Edinburgh, United Kingdom, EH16 4SA
Glasgow, United Kingdom, G31 2ER
London, United Kingdom, EC1M 6BQ
Stoke-on-Trent, United Kingdom, ST4 6QG
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01323153    
Other Study ID Numbers: WC25501
First Posted: March 25, 2011    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: July 30, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents