NCT00294567

Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)

Azelnidipine and Amlodipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients Undergoing Coronary Intervention by Serial Volumetric Intravascular Ultrasound Analysis in Junten Medical University (ALPS-J)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Juntendo University · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

In patients with hypertension who undergo elective PCI, the effects of long-term administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).

Detailed description

Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI. The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI. Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group for a total of 200 patients.

Conditions

• Hypertension
• Coronary Atherosclerosis

Interventions

Type	Name	Description
DRUG	Calcium channel blockers (amlodipine, azelnidipine)	Drug: amlodipine Drug: azelnidipine

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-05-01
• Completion: 2011-01-01
• First posted: 2006-02-22
• Last updated: 2021-05-14

Locations

1 site across 1 country: Japan