Aliskiren Effect on Aortic Plaque Progression

NCT01417104 | Terminated Phase 2 Results

• 1 other identifier: CSPP100AUS33T
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to assess the effectiveness of short term (\~9 months) Aliskiren/Placebo therapy to slow down the progression of atherosclerotic disease in thoracic and abdominal aorta. This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of the aortic wall. Aliskiren is an FDA approved drug for hypertension but in this study is used for a new indication. Recent studies with animals have shown that Aliskiren therapy reduces the atherosclerotic plaque. Therefore, in this study, the investigators would like to evaluate whether the investigational drug Aliskiren, which is not FDA approved for this indication has the same beneficial effects in people with atherosclerotic disease.

Conditions

Atherosclerosis

Keywords

plaque; magnetic resonance imaging (MRI); high blood pressure; MI; heart attack; CVA; stroke; PAD

Outcome Measures

Primary Outcomes (1)

• Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment

  All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements. An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated.

  Baseline and end of treatment ( 17 to 36 weeks)

Secondary Outcomes (1)

• Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment

  Baseline and end of treatment ( 17 to 36 weeks)

Other Outcomes (1)

• Change From Baseline in Resting Diastolic Blood Pressure

  baseline to end of treatment ( up to 36 weeks)

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR

Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day

Drug: Aliskiren

Placebo

PLACEBO COMPARATOR

Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)

Drug: Placebo

Interventions

Aliskiren DRUG

150 mg/300mg

Also known as: Tekturna

Aliskiren

Placebo DRUG

150mg/300mg

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ohio State University: lead
• Novartis: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Deiuliis J, Mihai G, Zhang J, Taslim C, Varghese JJ, Maiseyeu A, Huang K, Rajagopalan S. Renin-sensitive microRNAs correlate with atherosclerosis plaque progression. J Hum Hypertens. 2014 Apr;28(4):251-8. doi: 10.1038/jhh.2013.97. Epub 2013 Oct 24.

  PMID: 24152824 DERIVED

• Mihai G, Varghese J, Kampfrath T, Gushchina L, Hafer L, Deiuliis J, Maiseyeu A, Simonetti OP, Lu B, Rajagopalan S. Aliskiren effect on plaque progression in established atherosclerosis using high resolution 3D MRI (ALPINE): a double-blind placebo-controlled trial. J Am Heart Assoc. 2013 May 17;2(3):e004879. doi: 10.1161/JAHA.112.004879.

  PMID: 23686372 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Plaque, Amyloid; Hypertension; Myocardial Infarction; Stroke

Interventions

aliskiren; Sugars

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Sanjay Rajagopalan, MD
• Organization: The Ohio State University

sanjay.rajagopalan@osumc.edu

614-247-7760

Study Officials

• Sanjay Rajagopalan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 16, 2011
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 11, 2017
• Results First Posted: December 31, 2012

Record last verified: 2017-05

Locations

US (1)