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CompletedNCT00294567Updated May 14, 2021

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

A Phase 4 interventional study of Calcium channel blockers (amlodipine, azelnidipine) in Hypertension and Coronary Atherosclerosis, sponsored by Juntendo University. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Juntendo University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
199
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Hypertension
  • Coronary Atherosclerosis

Keywords

  • Hypertension
  • PCI
  • Calcium Channel Blockers
  • IVUS
  • Plaque
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 199 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Juntendo University is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: Between 20 and 79 years (at the time of giving informed consent).
  • Sex: Either sex.
  • Admission status: Outpatients.
  • Patients requiring treatment for hypertension according to the JSH 2004 hypertension therapy guidelines before beginning this study
  • Patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study.
  • Patients who are scheduled to undergo elective PCI.

Exclusion criteria

Exclusion Criteria:

  • Patients with acute coronary syndrome (ACS).
  • Patients who have experienced Q-wave myocardial infarction within 4 weeks before beginning this study.
  • Patients with renal dysfunction (serum creatinine >2.0 mg/dL).
  • Patients in whom PCI is unsuccessful.
  • Patients with cardiogenic shock.
  • Patients with moderate or severe congestive heart failure.
  • Patients with 50% or more stenosis of the main trunk of the left coronary artery.
  • Patients with other problems whom the investigator considers unsuitable for this study.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
199 participants (actual)

Study arms

  • Active comparator
    1

    Amlodipine

    Drug: Calcium channel blockers (amlodipine, azelnidipine)

  • Active comparator
    2

    Azelnidipine

    Drug: Calcium channel blockers (amlodipine, azelnidipine)

Interventions

  • DrugCalcium channel blockers (amlodipine, azelnidipine)

    Drug: amlodipine Drug: azelnidipine

06

What researchers measure

Primary outcomes

  1. Percent change in plaque volume from the baseline value. (IVUS) Percent change in plaque volume = (plaque volume after 48 weeks of drug administration - baseline plaque volume) / baseline plaque volume

    Time frame: 48Weeks

Secondary outcomes

  1. Change of plaque volume from the baseline value. (IVUS) Amount change and percent change in Minimal lumen diameter and % stenosis. (Quantitative Coronary Analysis) Change of intimal thickening volume in-stent.

    Time frame: 48Weeks

  2. Correlativity of plaque volume and inflammatory laboratory parameters (hs-CRP, MCP-1, PTX-3) Correlativity of laboratory parameters and blood pressure. Correlativity of plaque volume and antioxidant laboratory parameters (LPO, 8-isoprostane)

    Time frame: 48Weeks

  3. The following treatments and incidence of events, Changes from baseline of laboratory parameters (TC, LDL-C,TG, HDL-C, hs-CRP, MCP-1, LPO, 8-isoprostane, PTX-3) after 48 weeks of drug administration. Correlativity of plaque volume and blood pressure.

    Time frame: 48Weeks

07

Study locations

1 site
  • Department of Cardiology, Juntendo University School of Medicine
    Tokyo, Japan
08

References and documents

Publications

  • Miyauchi K, Daida H. [Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo Medical University]. Nihon Naika Gakkai Zasshi. 2012 Oct 10;101(10):3002-11. doi: 10.2169/naika.101.3002. No abstract available. Japanese. PubMed 23214115 ↗
  • Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H. Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J. 2011;75(5):1071-9. doi: 10.1253/circj.cj-11-0141. Epub 2011 Apr 7. PubMed 21471671 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00294567
Lead sponsor
Juntendo University
Collaborators
Japan Heart Foundation
Responsible party
Sponsor
First posted
Feb 22, 2006
Start date
Dec 2005
Primary completion
May 2009
Completion
Jan 2011
Last update
May 14, 2021

Study contacts

HIROYUKI MD DAIDA
study chair · Director of Cardiology Professor of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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