Clinical trial NCT00658515: A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 15871
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Incidence of Cardiovascular Mortality and Morbidity
timeFrame: From date of randomization to first event up to 48 months
Secondary outcomes:
measure: Composite Endpoint:All Cause Mortality
timeFrame: Throughout Study, up to 53 Months
measure: Change From Baseline for HDL Cholesterol
timeFrame: At 53 Months
measure: Adverse Events, Lab Parameters, Vital Signs, ECG
timeFrame: Throughout Study, up to 53 Months
Other outcomes:
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state: Tennessee
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city: Humble
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city: Killeen
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city: Lubbock
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city: Odessa
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city: Plano
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city: Round Rock
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city: San Antonio
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city: Tomball
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city: Tyler
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city: Tyler
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city: Victoria
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city: Layton
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city: Burke
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city: Manassas
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city: Midlothian
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city: Roanoke
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city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Johannesburg
country: South Africa
city: Kuilsriver
country: South Africa
city: Lyttelton, Pretoria
country: South Africa
city: Panorama
country: South Africa
city: Pinelands
country: South Africa
city: Pretoria
country: South Africa
city: Somerset West
country: South Africa
city: Vitoria
country: Spain
state: Alava
city: San Juan de Alicante
country: Spain
state: Alicante
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Figueres
country: Spain
state: Girona
city: Santiago de Compostela
country: Spain
state: LA Coruña
city: Majadahonda
country: Spain
state: Madrid
city: Málaga
country: Spain
state: Malaga
city: Pamplona
country: Spain
state: Navarra
city: Vigo
country: Spain
state: Pontevedra
city: Seville
country: Spain
state: Sevilla
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Guadalajara
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Tarragona
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Falun
country: Sweden
city: Goteborg
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Västerås
country: Sweden
city: Fribourg
country: Switzerland
city: Geneve
country: Switzerland
city: Kreuzlingen
country: Switzerland
city: Lugano
country: Switzerland
city: Luzern
country: Switzerland
city: Münsterlingen
country: Switzerland
city: Wolhusen
country: Switzerland
city: Airdrie
country: United Kingdom
city: Barnet
country: United Kingdom
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bradford
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Chertsey
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Larbert
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Luton
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Middlesex
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Nuneaton
country: United Kingdom
city: Paisley
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Stockport
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.