Dal-OUTCOMES Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

Click here to download slides for Dal-OUTCOMES Trial.

Official Title

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

Objective

The objective of this trial is to study the effect of dalcetrapib on cardiovascular mortality and morbidity in patients with recent acute coronary syndrome in patients on statin therapy.

Timeline

Timeline
Start Date	April 1, 2008
Run-In Period	4-12 weeks
End Date	November 2012
Status	Completed

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00658515.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase III
Study Design
Allocation	Randomized
Endpoint	Safety/Efficacy Study
Interventional Model	Parallel Assignment
Masking	Double Blind
Study Details
Primary Purpose	Treatment
Condition	Coronary Heart Disease
Intervention	Dalcetrapib (600mg po daily)
Study Arms	Dalcetrapib 600 mg daily Placebo
Population Size	15865

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00658515.

Eligibility Criteria

Inclusion Criteria

• Patients older than 45 years
• Patients on any statin therapy at any dose, previous hospitalization for acute coronary syndrome
• Patients with no cardiac biomarker elevation but with ECG changes that were not presumed to be previously present, or evidence of obstructive coronary disease, patients with myocardial infarction who underwent percutaneous coronary intervention
• Patients with symptomatic congestive heart failure but LVEF > 40%

Exclusion Criteria

• Triglyceride level above 400 mg/dL
• Pregnant or breast-feeding females
• Females with child-bearing potential who are not on effective contraception
• Symptomatic congestive heart failure by end of run-in period
• Hemoglobin ≤ 10 g/dL at end of run-in period
• Uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
• HbA1c > 10 on second visit
• Renal insufficiency with creatinine > 2.2 mg/dL or clinically apparent liver disease or liver function tests > 1.5 above upper normal limit at end of run-in period
• CPK > 3 times upper normal limit at 2nd visit
• Use of other anti-lipidemic agents except Ezetimibe or fish oil
• Use of other medications that increase HDL-C, previous exposure to CETP inhibitors
• Malignancy within 3 years
• Short life expectancy
• Alcohol or drug abuse within 5 years
• Hypersensitivity reactions to trial medications of components in placebo
• Other significant clinical and investigational conditions that the investigator finds important

The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00658515.

Outcomes

Primary Outcomes

Death from coronary heart disease, coronary events that are listed as myocardial infarction, unstable angina with evidence of acute myocardial ischemia, cardiac arrest with resuscitation, and stroke.

Secondary Outcomes

Unexpected coronary revascularization that does not include restenosis revascularization, death from any cause, change of lipoprotein and inflammatory markers levels.

Publications

Results

• 21% and 19% of patients on dalcetrapib and on placebo respectively were discontinued for unrelated reasons.

• At least 80% adherence was documented in 89% of both study groups.

• HDL increased 31-40% from baseline in dalcetrapib vs. 4-11% from baseline in placebo.

• Dalcetrapib had a minimal effect on LDL, fasting plasma glucose, or HbA1c.

• After 3 months of treatment, triglyceride increased 6-17% in placebo vs. 4-10% in dalcetrapib (p<0.001).

• Dalcetrapib had no significant effect on primary end point or the frequency of any primary end point component with a hazard ratio of 1.04 only.

• No association between primary end point and either baseline HDL levels or the HDL change after 1 month following treatment. Similar non-significant results were documented for apolipoprotein A1 levels in both groups.

• After 3 months of treatment, there is a significant 18% in CRP difference between dalcetrapib and placebo; whereby CRP levels were 1.6 mg/L in dalcetrapib and 1.4 mg/L in placebo (p<0.001).
• Higher blood pressure values by 0.6 mm Hg and diarrhea were more commonly seen in the dalcetrapib group (p<0.001).

Conclusion

Dalcetrapib can increase HDL levels but has no effect on decreasing rate of recurring cardiovascular events in patients with recent history of acute coronary syndrome.