Methods:

AQUARIUS (Aliskiren Quantitative Atherosclerosis Regression Intravascular Ultrasound Study) was a double-blind, randomized, multicenter trial (n = 613). Eligible participants had coronary artery disease (at least one 20% stenosis on clinically indicated coronary angiography and a target vessel for imaging with <50% obstruction), prehypertension (systolic blood pressure between 125 and 139 mm Hg and diastolic blood pressure <90 mm Hg), and two additional cardiovascular risk factors. Participants were randomized to receive 300 mg of aliskiren (n = 305) or placebo (n = 308) taken orally daily for 104 weeks. Following coronary angiography, baseline imaging of the target vessel was performed with intravascular ultrasound (IVUS); repeat examination was performed after at least 72 weeks of treatment. The primary efficacy parameter was the change in percent atheroma volume (PAV) from baseline to study completion.