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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Disease (CAD), Coronary Atherosclerosis

Intervention / Treatment
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* Drug: Placebo
* Drug: Aliskiren


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br>Aliskiren 300 mg | Drug: Aliskiren<br>* 300 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS | Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS 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 | 
| Patients That Demonstrated Evidence of Atheroma Regression | Atheroma regression is defined as change from baseline to endpoint in PAV <0 . | Baseline to endpoint (104 weeks) | 
| Number of Patients With Adverse Events, Serious Adverse Events, and Death | overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity. | 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD, coronary artery disease, coronary atherosclerosis, coronary angiography, IVUS, intravascular ultrasound, plasma renin activity, renin angiotensin aldosterone system,, direct renin inhibitors, coronary atheroma