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

This study has been completed.
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
Juntendo University Hospital
ClinicalTrials.gov Identifier:
NCT00294567
First received: February 20, 2006
Last updated: June 2, 2011
Last verified: October 2008
  Purpose

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).


Condition Intervention Phase
Hypertension
Coronary Atherosclerosis
Drug: Calcium channel blockers (amlodipine, azelnidipine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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)

Resource links provided by NLM:


Further study details as provided by Juntendo University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2005
Study Completion Date: January 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Amlodipine
Drug: Calcium channel blockers (amlodipine, azelnidipine)
Drug: amlodipine Drug: azelnidipine
Active Comparator: 2
Azelnidipine
Drug: Calcium channel blockers (amlodipine, azelnidipine)
Drug: amlodipine Drug: azelnidipine

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00294567

Locations
Japan
Department of Cardiology, Juntendo University School of Medicine
Tokyo, Japan
Sponsors and Collaborators
Juntendo University Hospital
Japan Heart Foundation
Investigators
Study Chair: HIROYUKI MD DAIDA Director of Cardiology Professor of Medicine
  More Information

No publications provided by Juntendo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: No
ClinicalTrials.gov Identifier: NCT00294567     History of Changes
Other Study ID Numbers: JHF-17NOV2005
Study First Received: February 20, 2006
Last Updated: June 2, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Juntendo University Hospital:
Hypertension
PCI
Calcium Channel Blockers
IVUS
Plaque

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypertension
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Calcium Channel Blockers
Amlodipine
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 26, 2014