Clinical trial NCT00853827: Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients
Official title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Coronary Atherosclerosis
Keywords: CAD
coronary artery disease
coronary atherosclerosis
coronary angiography
IVUS
intravascular ultrasound
plasma renin activity
renin angiotensin aldosterone system,
direct renin inhibitors
coronary atheroma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2009-03-02
Enrollment: 613
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.


Eligibility criteria: Inclusion Criteria:

* Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP \< 90mmHg.
* Patients with or without current treatment for hypertension
* Angiographic evidence of coronary artery disease
* At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

* Baseline IVUS determined unacceptable
* Patients requiring treatment with disallowed study medications
* Patients with clinically significant heart disease
* Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of \< 25%
* Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

  * Angiotensin converting enzyme inhibitors
  * Angiotensin receptor blockers
  * aldosterone receptor blockers or a direct renin inhibitor.
* Other conditions may apply

Primary outcomes:
measure: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
timeFrame: Baseline, 104 weeks
Secondary outcomes:
measure: Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS
timeFrame: Baseline, 104 weeks
measure: Patients That Demonstrated Evidence of Atheroma Regression
timeFrame: Baseline to endpoint (104 weeks)
measure: Number of Patients With Adverse Events, Serious Adverse Events, and Death
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Boulder
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Farmington
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hudson
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Port Charlotte
country: United States
facility: Novartis Investigative Site
state: Florida
city: Safety Harbor
country: United States
facility: Novartis Investigative Site
state: Florida
city: Decatur
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Elkhart
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Covington
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Flint
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Kalamazoo
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Midland
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Petoskey
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saginaw
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Paul
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Ridgewood
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novartis Investigative Site
state: New Mexico
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Syracuse
country: United States
facility: Novartis Investigative Site
state: New York
city: Williamsville
country: United States
facility: Novartis Investigative Site
state: New York
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Bend
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Hillsboro
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Danville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Oak Ridge
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Katy
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: New Lambton Heights
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Anderlecht
country: Belgium
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Genk
country: Belgium
facility: Novartis Investigative Site
city: Ottignies
country: Belgium
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Le Plessis Robinson
country: France
facility: Novartis Investigative Site
city: Pessac Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Coburg
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Pecs
country: Hungary
facility: Novartis Investigative Site
state: Baranya
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Arezzo
country: Italy
facility: Novartis Investigative Site
state: AR
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: BG
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Sesto San Giovanni
country: Italy
facility: Novartis Investigative Site
state: MI
city: Massa
country: Italy
facility: Novartis Investigative Site
state: MS
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Novara
country: Italy
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Kraków
country: Poland
facility: Novartis Investigative Site
city: Lódz
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Oviedo
country: Spain
facility: Novartis Investigative Site
state: Asturias
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Vigo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Majadanonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Galdakano
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.
citation: Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.