Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

NCT00853827 | Completed Phase 3 Results

• 2 other identifiers: CSPP100A23662008-006447-40
• Study Type: interventional
• Target: 613
• Locations: 11 countries
• Sites: 129

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.

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment

  Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases

  Baseline, 104 weeks

Secondary Outcomes (3)

• Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS

  Baseline, 104 weeks

• Patients That Demonstrated Evidence of Atheroma Regression

  Baseline to endpoint (104 weeks)

• Number of Patients With Adverse Events, Serious Adverse Events, and Death

  104 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Aliskiren 300 mg

Drug: Aliskiren

Interventions

Placebo DRUG

Placebo

1

Aliskiren DRUG

300 mg

2

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• The Cleveland Clinic: collaborator

Study Sites (129)

Novartis Investigative Site

Mobile, Alabama, 36693, United States

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Novartis Investigative Site

Phoenix, Arizona, 85054, United States

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Tucson, Arizona, 85723-0001, United States

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Tucson, Arizona, 85745, United States

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Novartis Investigative Site

Los Angeles, California, 90033, United States

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Novartis Investigative Site

Los Angeles, California, 90095, United States

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San Diego, California, 92161, United States

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Stockton, California, 95204, United States

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Torrance, California, 90502, United States

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Novartis Investigative Site

Boulder, Colorado, 80304, United States

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Novartis Investigative Site

Farmington, Connecticut, 06030-3100, United States

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Novartis Investigative Site

Washington D.C., District of Columbia, 20010, United States

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Novartis Investigative Site

Washington D.C., District of Columbia, 20037, United States

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Gainesville, Florida, 32610, United States

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Hudson, Florida, 34667, United States

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Miami, Florida, 33137-3732, United States

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Port Charlotte, Florida, 33952, United States

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Safety Harbor, Florida, 34695, United States

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Decatur, Georgia, 30033, United States

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Elkhart, Indiana, 46514, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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Covington, Louisiana, 70433, United States

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Columbia, Maryland, 21044, United States

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Boston, Massachusetts, United States

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Flint, Michigan, 48532, United States

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Kalamazoo, Michigan, 49048, United States

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Midland, Michigan, 48640, United States

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Petoskey, Michigan, 49770, United States

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Saginaw, Michigan, 48601, United States

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Rochester, Minnesota, 55905-0001, United States

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Saint Paul, Minnesota, 55102, United States

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Columbia, Missouri, 65212, United States

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Ridgewood, New Jersey, 07450, United States

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Albuquerque, New Mexico, 87131-5271, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10011, United States

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Syracuse, New York, 13210-1640, United States

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Williamsville, New York, 14221, United States

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Raleigh, North Carolina, 27610, United States

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Fargo, North Dakota, 58122, United States

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Cleveland, Ohio, 44109-1998, United States

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Oklahoma City, Oklahoma, 73109, United States

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Tulsa, Oklahoma, 74104-4243, United States

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Bend, Oregon, 97701, United States

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Hillsboro, Oregon, 97123, United States

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Danville, Pennsylvania, 17822-2001, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Johnson City, Tennessee, 37604, United States

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Memphis, Tennessee, 38104, United States

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Oak Ridge, Tennessee, 37830, United States

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Dallas, Texas, 75226, United States

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Katy, Texas, 77493, United States

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San Antonio, Texas, 78229-3900, United States

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Buenos Aires, Buenos Aires, C1039AAP, Argentina

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Buenos Aires, Buenos Aires, C1210AAP, Argentina

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Buenos Aires, Buenos Aires, C1280AEB, Argentina

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Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Buenos Aires, Buenos Aires, C1428DCO, Argentina

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Buenos Aires, Buenos Aires F.D., C1180AAX, Argentina

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Corrientes, Corrientes Province, 3400, Argentina

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Rosario, Santa Fe Province, C2000DSR, Argentina

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Camperdown, New South Wales, 2050, Australia

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Liverpool, New South Wales, 2170, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Adelaide, South Australia, 5000, Australia

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Clayton, Victoria, 3168, Australia

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Aalst, Belgium, 9300, Belgium

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Aalst, 9300, Belgium

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Anderlecht, 1070, Belgium

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Brussels, 1000, Belgium

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Brussels, 1200, Belgium

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Charleroi, 6000, Belgium

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Genk, 3600, Belgium

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Ottignies, 1340, Belgium

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Edmonton, Alberta, T5H 3V9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Winnipeg, Manitoba, R2H 3C3, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1V 4G5, Canada

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Créteil, 94010, France

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Le Plessis-Robinson, 92350, France

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Pessac, 33604, France

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Toulouse, 31059, France

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Coburg, 96450, Germany

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Essen, 45122, Germany

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Frankfurt, 60316, Germany

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Hamburg, 20099, Germany

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Hamburg, 20246, Germany

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Leipzig, 04289, Germany

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Ludwigshafen, 67063, Germany

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München, 81737, Germany

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Neuss, 41464, Germany

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Pécs, Baranya, 7621, Hungary

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Budapest, Hungary, 1122, Hungary

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Budapest, 1134, Hungary

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Debrecen, 4032, Hungary

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Szeged, 6720, Hungary

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Arezzo, AR, 52100, Italy

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Bergamo, BG, 24128, Italy

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Milan, MI, 20132, Italy

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Rozzano, MI, 20089, Italy

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Sesto San Giovanni, MI, 20099, Italy

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Massa, MS, 54100, Italy

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Parma, PR, 43100, Italy

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Roma, RM, 00185, Italy

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Siena, SI, 53100, Italy

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Novara, 28100, Italy

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Krakow, Poland, 31-531, Poland

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Bialystok, 15-276, Poland

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Lódz, 90-549, Poland

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Warsaw, 04-628, Poland

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Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

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Barcelona, Barcelona, 08025, Spain

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Novartis Investigative Site

Galdakano, Basque Country, 48960, Spain

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Santander, Cantabria, 39008, Spain

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Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Santiago de Compostela, Galicia, 15706, Spain

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Novartis Investigative Site

Vigo, Galicia, 36200, Spain

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Madrid, Madrid, 28040, Spain

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Novartis Investigative Site

Madrid, Madrid, 28046, Spain

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Novartis Investigative Site

Majadanonda, Madrid, 28220, Spain

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Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

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Related Publications (2)

• 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.

  PMID: 26523993 DERIVED

• 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.

  PMID: 23999933 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 3, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-05

Locations

PL (4); DE (9); US (54); IT (10); ES (13); CA (9); HU (5); FR (4); BE (8); AR (8); AU (5)