Phase 3
Completed N=15,871
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Source: ClinicalTrials.gov NCT00658515 ↗Enrolled (actual)
15,871
Serious AEs
21.3%
Results posted
Jan 2020
Primary outcomePrimary: Incidence of Cardiovascular Mortality and Morbidity — 0.034050; 0.032759 Event per Patient Years of Followup
◆ Published Evidence
Established
95citations · ~12 / year
Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial.
Summary
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
Linked Publications (5)
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Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial.
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Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes.
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Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease.
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Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure.
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Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Cardiovascular Mortality and Morbidity |
0.034050; 0.032759 | — |
| SECONDARY Composite Endpoint:All Cause Mortality |
226; 229 | — |
| SECONDARY Change From Baseline for HDL Cholesterol |
44.96; 15.60 | — |
| SECONDARY Adverse Events, Lab Parameters, Vital Signs, ECG |
— | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=45 years of age;
- recently hospitalized for ACS;
- clinically stable;
- receiving evidence-based medical and dietary management of dyslipidemia.
Exclusion Criteria
- uncontrolled diabetes;
- clinically unstable;
- severe anemia;
- uncontrolled hypertension;
- concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
Data sourced from ClinicalTrials.gov (NCT00658515) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.