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NCT Number: NCT00294567

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

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).

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Key information

Conditions

Hypertension Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Vascular Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Juntendo University School of Medicine

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Calcium channel blockers (amlodipine, azelnidipine)

Drug

Drug: amlodipine Drug: azelnidipine

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

Sponsors and collaborators

Lead sponsor

Juntendo University

Other

Collaborators

  • Japan Heart Foundation

Registry information

Official study title

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)

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Feb 22, 2006
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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