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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00658515




Registration number
NCT00658515
Ethics application status
Date submitted
28/03/2008
Date registered
15/04/2008
Date last updated
3/01/2020

Titles & IDs
Public title
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
Scientific 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
Secondary ID [1] 0 0
2007-005103-18
Secondary ID [2] 0 0
NC20971
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dalcetrapib (RO4607381)
Treatment: Drugs - Evidence-based medical care for Acute Coronary Syndrome
Treatment: Drugs - Placebo

Experimental: Dalcetrapib (RO4607381) -

Placebo comparator: Placebo -


Treatment: Drugs: Dalcetrapib (RO4607381)
600mg po daily

Treatment: Drugs: Evidence-based medical care for Acute Coronary Syndrome
As prescribed

Treatment: Drugs: Placebo
po daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Cardiovascular Mortality and Morbidity
Timepoint [1] 0 0
From date of randomization to first event up to 48 months
Secondary outcome [1] 0 0
Composite Endpoint:All Cause Mortality
Timepoint [1] 0 0
Throughout Study, up to 53 Months
Secondary outcome [2] 0 0
Change From Baseline for HDL Cholesterol
Timepoint [2] 0 0
At 53 Months
Secondary outcome [3] 0 0
Adverse Events, Lab Parameters, Vital Signs, ECG
Timepoint [3] 0 0
Throughout Study, up to 53 Months

Eligibility
Key inclusion criteria
* adult patients, >=45 years of age;
* recently hospitalized for ACS;
* clinically stable;
* receiving evidence-based medical and dietary management of dyslipidemia.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* uncontrolled diabetes;
* clinically unstable;
* severe anemia;
* uncontrolled hypertension;
* concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
15871
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Epping
Recruitment hospital [5] 0 0
- Kingswood
Recruitment hospital [6] 0 0
- Wollongong
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- Cairns
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- Chermside
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- Milton
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- Woolloongabba
Recruitment hospital [11] 0 0
- Bedford Park
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- Box Hill
Recruitment hospital [13] 0 0
- Geelong
Recruitment hospital [14] 0 0
- Sale
Recruitment hospital [15] 0 0
- Joondalup
Recruitment hospital [16] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2450 - Coffs Harbour
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2137 - Concord
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3076 - Epping
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2747 - Kingswood
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2500 - Wollongong
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4870 - Cairns
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4032 - Chermside
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4064 - Milton
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4102 - Woolloongabba
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5042 - Bedford Park
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3128 - Box Hill
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3220 - Geelong
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3850 - Sale
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6027 - Joondalup
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00658515
Trial related presentations / publications
Schwartz GG, Leiter LA, Ballantyne CM, Barter PJ, Black DM, Kallend D, Laghrissi-Thode F, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Preiss D, Shah PK, Tardif JC, Kittelson J. Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease. Diabetes Care. 2020 May;43(5):1077-1084. doi: 10.2337/dc19-2204. Epub 2020 Mar 6.
Salahuddin T, Kittelson J, Tardif JC, Shah PK, Olsson AG, Nicholls SJ, Leitersdorf E, Leiter LA, Kallend D, Black DM, Barter PJ, Ballantyne CM, Schwartz GG. Association of high-density lipoprotein particle concentration with cardiovascular risk following acute coronary syndrome: A case-cohort analysis of the dal-Outcomes trial. Am Heart J. 2020 Mar;221:60-66. doi: 10.1016/j.ahj.2019.12.003. Epub 2019 Dec 16.
Schwartz GG, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, McMurray JJV, Nicholls SJ, Olsson AG, Shah PK, Tardif JC, Kittelson J. Association of Lipoprotein(a) With Risk of Recurrent Ischemic Events Following Acute Coronary Syndrome: Analysis of the dal-Outcomes Randomized Clinical Trial. JAMA Cardiol. 2018 Feb 1;3(2):164-168. doi: 10.1001/jamacardio.2017.3833.
Pitts R, Gunzburger E, Ballantyne CM, Barter PJ, Kallend D, Leiter LA, Leitersdorf E, Nicholls SJ, Shah PK, Tardif JC, Olsson AG, McMurray JJ, Kittelson J, Schwartz GG. Aldosterone Does Not Predict Cardiovascular Events Following Acute Coronary Syndrome in Patients Initially Without Heart Failure. J Am Heart Assoc. 2017 Jan 10;6(1):e004119. doi: 10.1161/JAHA.116.004119.
Tardif JC, Rhainds D, Brodeur M, Feroz Zada Y, Fouodjio R, Provost S, Boule M, Alem S, Gregoire JC, L'Allier PL, Ibrahim R, Guertin MC, Mongrain I, Olsson AG, Schwartz GG, Rheaume E, Dube MP. Genotype-Dependent Effects of Dalcetrapib on Cholesterol Efflux and Inflammation: Concordance With Clinical Outcomes. Circ Cardiovasc Genet. 2016 Aug;9(4):340-8. doi: 10.1161/CIRCGENETICS.116.001405. Epub 2016 Jul 14.
Schwartz GG, Abt M, Bao W, DeMicco D, Kallend D, Miller M, Mundl H, Olsson AG. Fasting triglycerides predict recurrent ischemic events in patients with acute coronary syndrome treated with statins. J Am Coll Cardiol. 2015 Jun 2;65(21):2267-75. doi: 10.1016/j.jacc.2015.03.544. Erratum In: J Am Coll Cardiol. 2015 Jul 21;66(3):334.
Tardif JC, Rheaume E, Lemieux Perreault LP, Gregoire JC, Feroz Zada Y, Asselin G, Provost S, Barhdadi A, Rhainds D, L'Allier PL, Ibrahim R, Upmanyu R, Niesor EJ, Benghozi R, Suchankova G, Laghrissi-Thode F, Guertin MC, Olsson AG, Mongrain I, Schwartz GG, Dube MP. Pharmacogenomic determinants of the cardiovascular effects of dalcetrapib. Circ Cardiovasc Genet. 2015 Apr;8(2):372-82. doi: 10.1161/CIRCGENETICS.114.000663. Epub 2015 Jan 11.
Schwartz GG, Olsson AG, Abt M, Ballantyne CM, Barter PJ, Brumm J, Chaitman BR, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Mundl H, Nicholls SJ, Shah PK, Tardif JC, Wright RS; dal-OUTCOMES Investigators. Effects of dalcetrapib in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Nov 29;367(22):2089-99. doi: 10.1056/NEJMoa1206797. Epub 2012 Nov 5.
Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.
Derks M, Abt M, Parr G, Meneses-Lorente G, Young AM, Phelan M. No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin. Expert Opin Investig Drugs. 2010 Oct;19(10):1135-45. doi: 10.1517/13543784.2010.509342.
Schwartz GG, Olsson AG, Ballantyne CM, Barter PJ, Holme IM, Kallend D, Leiter LA, Leitersdorf E, McMurray JJ, Shah PK, Tardif JC, Chaitman BR, Duttlinger-Maddux R, Mathieson J; dal-OUTCOMES Committees and Investigators. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. Am Heart J. 2009 Dec;158(6):896-901.e3. doi: 10.1016/j.ahj.2009.09.017.
Stein EA, Stroes ES, Steiner G, Buckley BM, Capponi AM, Burgess T, Niesor EJ, Kallend D, Kastelein JJ. Safety and tolerability of dalcetrapib. Am J Cardiol. 2009 Jul 1;104(1):82-91. doi: 10.1016/j.amjcard.2009.02.061.
Public notes

Contacts
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Hoffmann-La Roche
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00658515