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

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ClinicalTrials.gov Identifier: NCT00294567
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : June 3, 2011
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
Juntendo University Hospital

Brief 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).

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2005
Primary Completion Date : May 2009
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294567     History of Changes
Other Study ID Numbers: JHF-17NOV2005
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: June 3, 2011
Last Verified: October 2008

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

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